Clinical trial · Interventional
Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies
Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies
NCT00038376CI-TRIAL-00035490completedPhase 2ClinicalTrials.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)
The purpose of this study is to determine the response rate of patients with T-cell malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin (Accutane).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Lymphoma, T-Cell | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon Alpha | Drug | — | UNRESOLVED |
| Isotretinoin (Accutane) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Alpha-interferon + Isotretinoin
- interventionNames
- Drug: Isotretinoin (Accutane)
- Drug: Interferon Alpha
Primary outcomes (1)
- measure
- To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies.
- timeFrame
- 15 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologic proof of incurable T-cell malignancy or Hodgkin's disease, and not eligible for existing/higher priority protocols. Patients with Hodgkin's disease will be eligible only if they have failed at least a MOPP-like and ABVD-like regimen. 2. Patients should not have received chemotherapy, immunotherapy, hormonal therapy, or radiation therapy within three weeks of entry into the study and must have recovered from acute toxic effects of prior therapy. 3. Patients must have a life expectancy of at least 12 weeks and a performance status of less than or equal to 2 (Zubrod scale: Appendix A). 4. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with policies of the hospital. The only approved consent form is appended to this protocol. 5. Patients must have measurable or evaluable disease. 6. Patients must be greater than or equal to 18 years old. 7. Patients may receive no other concurrent chemotherapy, immunotherapy, or radiotherapy. 8. Patients should have adequate hepatic function with bilirubin of less than or equal to 2.0 mg%, and SGPT of less than or equal to 4 times the upper limits of normal. 9. Patients should have adequate renal function (defined as serum creatinine of less than or equal to 2.0 mg%). 10. Patients should have serum triglyceride level less than or equal to 2.5 times the upper limits of normal. 11. Patients may not have serious intercurrent medical illness. 12. Patients of child bearing potential must be practicing adequate contraception. 13. Patients will be eligible regardless of the extent of prior chemotherapy. Exclusion Criteria: 1\) Pediatric Patients under 18 years old.
References
Publications (0)
Data not yet available
No reference posted for this study.