Clinical trial · Interventional
PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pharmaceutical collaborator pulled funding.
Summary
Brief summary (as posted)
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Biological | — | UNRESOLVED |
| PEG-interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-Intron, BM-CSF and thalidomide
- interventionNames
- Biological: PEG-interferon alfa-2b
- Biological: GM-CSF
- Drug: thalidomide
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year
- description
- To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
Secondary outcomes (3)
- measure
- Duration of Response
- timeFrame
- time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed renal cell carcinoma
* Metastatic disease
* Measurable disease
* Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI
* Histologic confirmation required if measurable disease is confined to a solitary lesion
* The following are not considered measurable disease:
* Bone disease only
* Pleural or peritoneal metastases
* CNS lesions
* Irradiated lesions unless disease progression was documented after prior radiotherapy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 mg/dL
* No decompensated liver disease
Renal
* Creatinine ≤ 2.0 mg/dL
Immunologic
* No known or suspected hypersensitivity to interferon alfa or to any excipient or vehicle included in the formulation or delivery system
* No history of autoimmune disease
* No autoimmune hepatitis
* No immunosuppressed transplantation recipients
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after study participation
* No pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range
* No severe psychiatric condition or disorder, including suicidal ideation or attempt
* No other active malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior immunotherapy
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available