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

Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma

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.

OBJECTIVES:

• Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV solid tumors, lymphoma, or myeloma.
• Determine the maximum tolerated dose (MTD) of IFN-α1b given daily by subcutaneous injection in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of interferon alfa-1b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

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