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

October 11, 2015 updated by: The Cleveland Clinic

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

Completed

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

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195-5044
        • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Biological: recombinant interferon alpha-1b
interferon
Other Names:
  • Interferon
Drug: IFN
IFN daily
Other Names:
  • Interferon

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

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ernest C. Borden, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 11, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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