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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00276536
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Kidney Cancer Lymphoma Melanoma Multiple Myeloma Sarcoma Unspecified Adult Solid Tumor, Protocol Specific Biological: recombinant interferon alpha-1b Drug: IFN Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma
Study Start Date : January 2001
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
IFN weekly
 Biological: recombinant interferon alpha-1b
interferon
Other Name: Interferon

Drug: IFN
IFN daily
Other Name: Interferon


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276536


Locations
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United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195-5044
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Investigators
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Study Chair: Ernest C. Borden, MD The Cleveland Clinic
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00276536    
Other Study ID Numbers: CASE-CCF-3575
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-CCF-3575 ( Other Identifier: IRB )
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by The Cleveland Clinic:
stage IV melanoma
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Lymphoma
Melanoma
Multiple Myeloma
Neoplasms, Plasma Cell
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferons
Interferon-alpha