NCT00038376

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 1990

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 1990

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2002

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2005

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

15.2 years

First QC Date

May 30, 2002

Last Update Submit

October 25, 2018

Conditions

Lymphoma, T-CellMycosis FungoidesHematologic Neoplasms

Keywords

T-cell lymphomaaccutaneisotretinoinmycosis fungoidesT-cell malignancies

Outcome Measures

Primary Outcomes (1)

  • To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies.

    15 Years

Study Arms (1)

1

EXPERIMENTAL

Alpha-interferon + Isotretinoin

Drug: Isotretinoin (Accutane)Drug: Interferon Alpha

Interventions

Isotretinoin (Accutane)DRUG

0.5 mg/k (1.0 mg/k total) by mouth twice a day

Also known as: 13-cis-Retinoic Acid
1
Interferon AlphaDRUG

Starting dose of 3 MU injected under skin once a day for 12 weeks.

Also known as: Intron A, Interferon alfa-2b
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • 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).
  • 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.
  • Patients must have measurable or evaluable disease.
  • Patients must be greater than or equal to 18 years old.
  • Patients may receive no other concurrent chemotherapy, immunotherapy, or radiotherapy.
  • 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.
  • Patients should have adequate renal function (defined as serum creatinine of less than or equal to 2.0 mg%).
  • Patients should have serum triglyceride level less than or equal to 2.5 times the upper limits of normal.
  • Patients may not have serious intercurrent medical illness.
  • Patients of child bearing potential must be practicing adequate contraception.
  • Patients will be eligible regardless of the extent of prior chemotherapy.

You may not qualify if:

  • \) Pediatric Patients under 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma, T-CellMycosis FungoidesHematologic Neoplasms

Interventions

IsotretinoinInterferon-alphaIntronsInterferon alpha-2

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-Cell, CutaneousNeoplasms by SiteHematologic Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsDNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Study Officials

  • Razelle Kurzrock, MD, BS

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2002

First Posted

May 31, 2002

Study Start

May 8, 1990

Primary Completion

June 30, 2005

Study Completion

June 30, 2005

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

US(1)