Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT00014261
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced solid tumor that is refractory to standard therapy OR
* Histologically confirmed chemotherapy-naive advanced cancer for which no curative therapy or higher priority palliative chemotherapy exists
* Brain metastasis allowed
* No bone marrow involvement of tumor
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,500/mm\^3 AND/OR
* Platelet count greater than 100,000/mm\^3
Hepatic:
* ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
* No autoimmune hepatitis
Renal:
* Creatinine less than 2.5 times ULN
Cardiovascular:
* No severe coronary artery disease
* No congestive heart failure
Pulmonary:
* No severe chronic obstructive pulmonary disease
Gastrointestinal:
* No frequent vomiting
* No medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction, partial intestinal bypass, or external biliary diversion)
Other:
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No known or suspected hypersensitivity to imidazotetrazin, interferon alfa, or any excipient or vehicle included in the formulation or delivery system of study drug
* No history of autoimmune disease
* No preexisting severe psychiatric condition or history of severe psychiatric disorder (including suicidal ideation or attempt)
* No life-threatening condition or severe preexisting condition
* No uncontrolled thyroid abnormalities
* No nonmalignant systemic disease
* No active uncontrolled infection
* HIV negative
* No AIDS-related illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic agents (e.g., bi-specific antibodies, interleukin-2, or interferon) and recovered (excluding alopecia)
* No prior allogeneic, syngeneic, or autologous bone marrow or stem cell transplantation
* No other concurrent biologic therapy
* No concurrent colony stimulating factors or epoetin alfa for the prevention of myelotoxicity
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (more than 6 weeks for nitrosoureas, melphalan, or mitomycin) and recovered (excluding alopecia)
* No prior high-dose chemotherapy and stem cell transplantation
* No more than 3 prior chemotherapy regimens
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 6 weeks since prior wide-field radiotherapy to at least 25% of bone marrow (e.g., pelvic radiotherapy)
* More than 6 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
* Recovered from prior radiotherapy (excluding alopecia)
* No concurrent radiotherapy
Surgery:
* At least 4 weeks since prior major surgery
* At least 1 week since prior minor surgery
Other:
* At least 4 weeks since prior investigational therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00014261
Study Brief:
Protocol Section:
NCT00014261