Clinical trial · Interventional
PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
- 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: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with thalidomide may be an effective treatment for melanoma. PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with thalidomide works in treating patients with recurrent or metastatic melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Response rate as measured scans and tumor measurements every 8 weeks
- measure
- Qualitative and quantitative toxicities at 30 days following study treatment
Secondary outcomes (3)
- measure
- Progression-free survival by standard life table and Kaplan-Meier
- measure
- Overall survival by standard life table and Kaplan-Meier
- measure
- Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma, including any of the following: * Cutaneous melanoma * Ocular melanoma * Mucosal melanoma * Unidentified primary tumor * Recurrent or metastatic disease * Bidimensionally measurable or evaluable disease * Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * SWOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT ≤ 2 times ULN Renal * Creatinine ≤ 2 mg/dL Cardiovascular * None of the following conditions within the past 3 months: * Congestive heart failure * Second- or third-degree heart block * Myocardial infarction Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment * No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix * No concurrent blood, sperm, or ova donation PRIOR CONCURRENT THERAPY: Biologic therapy * Prior biologic therapy (e.g., interferon) allowed Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 28 days since prior radiotherapy Surgery * At least 28 days since prior surgery Other * No more than 2 prior systemic treatment regimens for metastatic malignant melanoma
References
Publications (0)
Data not yet available