Patients with prior malignancies, except treated non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative surgery without chemotherapy/radiation therapy > 5 years previously will be allowed. Cancer treated with curative surgery < 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.
STEP I: Patients with a history of prior malignancy are eligible provided they were treated with curative intent and do not require active therapy (currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast are not excluded)
Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screening.
Prior malignancy (other than non-invasive malignancy including in situ cervical cancer, Bowen's disease or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for 3 years before randomization
Previous malignancy, except for non-squamous-cell carcinoma of skin or carcinoma in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: History of other malignancy which could affect compliance with the protocol or interpretation of results; history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed; subjects with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in remission without treatment for >= 2 years prior to cycle 1, day 1; subjects with localized prostate cancer that has been treated with curative intent will be allowed
Concurrent other malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
Prior malignancies within the past 3 years (with allowance for adequately treated in situ carcinoma of the cervix uteri, and basal cell or localized squamous cell carcinoma of the skin treated with curative intent)
Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent > 5 years previously will be allowed. Cancer treated with curative intent < 5 years, which is in remission, will be reviewed on a case-by-case basis by the Protocol Officer or one of the Protocol Chairs.
Participant has prior malignancies, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ. Cancer treated with curative intent ? 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed. Randomization Exclusion Criteria
Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent > 5 years previously will be allowed. Cancer treated with curative intent ? 5 years previously will not be allowed unless approved by the Protocol Chairs and/or Protocol Officer.
Malignancy treated with curative intent and with no known active disease present for ? 3 years before enrollment
Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screening
Second malignancy requiring concurrent treatment or those with non-hematological malignancies (except non-melanoma skin cancers); cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Chair; cancer treated with curative intent > 5 years previously is allowed
Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission
Subject has a history of other malignancies prior to study entry, with the exception of:\r\n* Adequately treated in situ carcinoma of the breast or cervix uteri\r\n* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin\r\n* Prostate cancer with no plans for therapy of any kind\r\n* Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years; subjects with a history of cervical carcinoma in situ, superficial or no-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded
Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission
History of other active malignancies other than CLL within the past 3 years prior to study entry, with the exception of adequately treated in situ carcinoma or the cervix uteri or breast, basal cell or localized squamous cell carcinoma of the skin, previous malignancy confirmed and surgically resected (or treated with other modalities) with curative intent or without relapse for >= 2 years
Previous malignant disease (other than the target malignancy to be investigated in this trial) within 3 years prior to study treatment initiation. Subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ, previously treated with curative intent are NOT excluded. Subjects with other localized malignancies treated with curative intent need to be discussed with the Principal investigator.
Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent < 5 years prior to enrollment will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent > 5 years prior to enrollment is allowed.
Prior malignancy (other than in situ cervical cancer, or basal cell or squamous cell carcinoma of the skin), unless treated with curative intent and without evidence of disease for 3 years or longer
History (within 2 years prior to first study drug administration) of another malignancy unless the malignancy was treated with curative intent and likelihood of relapse is small. Subjects with a history of squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix may be enrolled.
Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, adequately treated in situ carcinoma of the breast or cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; malignancy treated with curative intent with no known active disease present for >= 3 years
Prior diagnosis of non-hematologic malignancy within 5 years of planned protocol therapy EXCEPT:\r\n* Diagnosis of breast ductal carcinoma in situ treated with curative intent\r\n* Diagnosis of prostate adenocarcinoma with Gleasons score =< 6 treated with curative intent\r\n* Non-melanomatous skin cancer
Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent > 5 years previously will be allowed; cancer treated with curative intent =< 5 years previously will not be allowed unless approved by the PI
History of a malignancy (other than head and neck cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years
A history of other malignancy with the exception of those treated with curative intent with no evidence of disease for 2 years
A history of other malignancy, unless treated with curative intent, and no evidence of disease for at least 2 years.
Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or the breast, unless they are successfully treated with curative intent for more than 2 years before entering the study
History of any treatment for cancer within the past two years other than basal cell or squamous cell carcinoma of the skin that has been treated with curative intent
History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
Second malignancies (excluding non-melanoma skin cancer) unless treated with curative intent and disease-free for 3 years
History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, adequately treated in situ carcinoma of the breast or cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin (i.e. malignancy not treated with curative intent or diagnosis within the past 2 years)
Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission
Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
Patients with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years; there will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, or other in situ carcinoma that has been adequately treated
History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally with curative intent
Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with history of cervical carcinoma in situ, superficial or non invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded. Subjects with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor.
History of other active malignancies other than CLL within the past 3 years prior to study entry, with the exception of:\r\n* Adequately treated in situ carcinoma or the cervix uteri or breast\r\n* Basal cell or localized squamous cell carcinoma of the skin\r\n* Previous malignancy confirmed and surgically resected (or treated with other modalities) with curative intent or without relapse for >= 2 years
Participant has a history of other malignancies prior to study entry, with the exception of: adequately treated in situ carcinoma of the breast or cervix uteri; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; or previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
History of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions: adequately treated in situ carcinoma of the cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Other malignancy (in addition to gastric cancer [GC]) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent
No active malignancy other than NSCLC; patients with a history of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast within the past 3 years must have been treated with curative intent; patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for > 3 years
Patients with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years; there will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated
History of a malignancy (other than melanoma) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
Prior malignancy, unless treated with curative intent and with no evidence of active disease present for > 5 years before screening
Second malignancy other than non-basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission
History of other malignancy up to 5 years prior to study entry which could affect compliance with the protocol or interpretation of results. History of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, low grade, early stage, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent, are generally eligible.
History of second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated with curative intent at least 2 years before trial entry
Current treatment, or treatment in the previous 24 months, for another non-melanoma malignancy, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix; patients treated with curative intent for other malignancies within 24 months may be enrolled on a case by case basis after discussion/approval with the study PI
History of another malignancy in the previous 3 years, except for history of in situ cancer that was treated surgically with curative intent, localized prostate cancer that has been treated surgically with curative intent, or basal or squamous cell skin cancer
Other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumour was successfully treated with curative intent at least 2 years prior to trial entry.*
Prior or concurrent malignancies (including myelodysplasia) except resected basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent < 5 years previously will not be allowed unless approved by the protocol chair; cancer treated with curative intent > 5 years previously will be allowed
Patients with prior malignancies except resected basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair; cancer treated with curative intent more than 5 years previously will be allowed
History of malignancy other than the underlying disease unless treated with a curative intent and/or no evidence of disease for at least 3 years (y) OR expected to be cured with SCT
Patients with prior malignancies, except resected non-melanoma or treated cervical carcinoma in situ. Cancer treated with curative intent ? 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.
Patients with prior malignancies except basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent > 5 years will be allowed; cancer treatment with curative intent =< 5 years will not be allowed
Patients with prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent > 5 years previously will be allowed; cancer treated with curative intent < 5 years previously will not be allowed unless approved by the protocol officer or one of the protocol chairs
Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent ? 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.
History of cancer other than prostate cancer (except squamous cell carcinoma of the skin that has been treated with curative intent)
Subject has prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent ? 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed.
Known other previous/current malignancy requiring treatment within ? 3 years except for liited disease treated with curative intent