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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer, Kidney Cancer, Lymphoma, Melanoma, Multiple Myeloma, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: recombinant interferon alpha-1b
* Drug: IFN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>IFN weekly | Biological: recombinant interferon alpha-1b<br>* interferon<br>* Other names: Interferon;Drug: IFN<br>* IFN daily<br>* Other names: Interferon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance and safety as measured by any ≥ Grade IV granulocyte toxicity or any Grade III toxicity thought to be drug related at 1 week after each course |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, unspecified adult solid tumor, protocol specific