Clinical trial · Interventional
Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma
Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma
NCT00276536CI-TRIAL-00019455IFNacompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IFN | Drug | — | UNRESOLVED |
| recombinant interferon alpha-1b | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- IFN weekly
- interventionNames
- Biological: recombinant interferon alpha-1b
- Drug: IFN
Primary outcomes (1)
- measure
- 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
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.