Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies

• Status: Completed
• Trial end date: 2005-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Isotretinoin

Criteria

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.