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

NCT00276536 | Completed Phase 1 DMC

• 2 other identifiers: CASE-CCF-3575P30CA043703
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

stage IV melanoma; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (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

  3 years

Study Arms (1)

Treatment

EXPERIMENTAL

IFN weekly

Biological: recombinant interferon alpha-1b; Drug: IFN

Interventions

recombinant interferon alpha-1b BIOLOGICAL

interferon

Also known as: Interferon

Treatment

IFN DRUG

IFN daily

Also known as: Interferon

Treatment

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195-5044, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Kidney Neoplasms; Lymphoma; Melanoma; Multiple Myeloma; Sarcoma

Interventions

interferon-alfa-1b; Interferons

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ernest C. Borden, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: January 1, 2001
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (1)