- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00276536
Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma (IFNa)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195-5044
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
IFN weekly
|
interferon
Other Names:
IFN daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ernest C. Borden, MD, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neuroendocrine Tumors
- Nevi and Melanomas
- Lymphoma
- Kidney Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Melanoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Interferon-alfa-1b
Other Study ID Numbers
- CASE-CCF-3575 (Other Identifier: IRB)
- P30CA043703 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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