Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in treating patients with stage IV solid tumors, lymphoma, or myeloma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Interferon-alfa-1b; Interferon-alpha; Interferons

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignancy, including, but not limited to, renal cell carcinoma, melanoma, Kaposi's sarcoma, breast carcinoma, lymphoma, myeloma, or tumors of endothelial origin

• Stage IV disease

• Refractory to standard therapy

• Measurable or evaluable disease

• Evaluable disease can include clinically or radiographically nonmeasurable tumor or specific tumor markers

• Patients with prior solitary CNS metastasis allowed

• Must have had prior definitive therapy ≥ 3 months previously

• No requirement for glucocorticoids unless for physiologic replacement

• No multiple CNS metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 1.3 times upper limit of normal (ULN) OR

• Creatinine clearance of 60 mL/min

• Bilirubin ≤ 1.3 times ULN

• AST ≤ 5 times ULN

• No pregnant or lactating women

• Fertile women and men, unless surgically sterile, must use effective contraception

• No history of serious cardiac arrhythmia or cardiac arrhythmia requiring treatment

• No congestive heart failure

• No angina pectoris

• No New York Heart Association class III or IV disease

• No other severe cardiovascular disease

• No known seizure disorder

• No known HIV or hepatitis B surface antigen positivity

• No active clinical infection requiring antibiotics within the past 7 days

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 months since prior interferon therapy and/or ≤ 400 million units of interferon

• At least 3 weeks since prior major surgery requiring general anesthesia

• At least 3 weeks since prior radiotherapy or chemotherapy

• Treatment with hormones or other chemotherapeutic agents may not be administered except for steroids given for preexisting adrenal failure or hormones administered for nondisease-related conditions (e.g., insulin for diabetes)

• No prior organ allograft

• No concurrent dexamethasone, other steroidal antiemetics, or anti-inflammatories

• No concurrent palliative radiotherapy