Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Blood Cancer, Lymphoma, Hematology, Kidney Cancer |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 4/21/2016 |
Start Date: | January 2001 |
End Date: | January 2004 |
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.
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.
- 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
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