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

NCT00005969 | Withdrawn Phase 2

• 5 other identifiers: ID99-255P30CA016672MDA-ID-99255NCI-103CDR0000067952
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma; recurrent/refractory childhood Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Patient Response Rate

  28 Day Cycles

Study Arms (1)

Liposomal Tretinoin

EXPERIMENTAL

Liposome by vein (IV) over 30 minutes every other day for 28 days and Chemotherapy.

Drug: Chemotherapy; Drug: Tretinoin Liposome

Interventions

Chemotherapy DRUG

Liposomal Tretinoin

Tretinoin Liposome DRUG

Liposome by vein (IV) over 30 minutes every other day for 28 days

Also known as: ATRAGEN

Liposomal Tretinoin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Recurrence

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Andreas H. Sarris, MD, PhD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: April 28, 2004
• Study Start: September 1, 1999
• Primary Completion: January 1, 2001
• Last Updated: February 20, 2012

Record last verified: 2012-02