Liposomal Tretinoin in Treating Patients With Recurrent or Refractory Hodgkin's Disease

This study has been withdrawn prior to enrollment.
(Study withdrawn.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00005969
First received: July 5, 2000
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin in treating patients who have recurrent or refractory Hodgkin's disease.


Condition Intervention Phase
Lymphoma
Drug: Chemotherapy
Drug: Tretinoin Liposome
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of ATRAGEN (Liposomal Tretinoin) in Patients With Relapsed or Refractory Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Response Rate [ Time Frame: 28 Day Cycles ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 1999
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposomal Tretinoin
Liposome by vein (IV) over 30 minutes every other day for 28 days and Chemotherapy.
Drug: Chemotherapy Drug: Tretinoin Liposome
Liposome by vein (IV) over 30 minutes every other day for 28 days
Other Name: ATRAGEN

Detailed Description:

OBJECTIVES: I. Determine the response rate, failure free survival, and progression free survival of patients with recurrent or refractory Hodgkin's disease treated with tretinoin liposome. II. Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior response to treatment (refractory vs recurrent vs post marrow transplant). Patients receive tretinoin liposome IV over 30 minutes every other day for 28 days. Treatment continues every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are eligible for stem cell or marrow transplant receive at least 2 courses before crossing over to transplant. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 105 patients (35 per strata) will be accrued for this study over 2-3 years.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory Hodgkin's disease Recurrent after partial or complete response after initial therapy OR Refractory after no response or progression after initial therapy At least 2 prior treatment regimens (radiotherapy considered separate if not part of planned combined modality) Bidimensionally measurable disease No active CNS disease

PATIENT CHARACTERISTICS: Age: 12 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 500/mm3 Platelet count at least 20,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT less than 4 times upper limit of normal Renal: Creatinine no greater than 3.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception Must not be eligible or willing to undergo treatment of a higher priority HIV negative No other prior malignancies within the last 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix treated with curative intent No other concurrent serious illness or active infection No mental or social reasons that may preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior autologous stem cell or marrow transplant No prior allogenic stem cell or marrow transplant Chemotherapy: See Disease Characteristics Must be recovered from last regimen No prior retinoids, including tretinoin Endocrine therapy: No concurrent steroids Radiotherapy: See Disease Characteristics Must be recovered from last regimen Surgery: Not specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005969

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Andreas H. Sarris, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00005969     History of Changes
Other Study ID Numbers: ID99-255, P30CA016672, MDA-ID-99255, NCI-103, CDR0000067952
Study First Received: July 5, 2000
Last Updated: February 17, 2012
Health Authority: United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 16, 2014