Arsenic Trioxide in Treating Patients With Relapsed or Refractory Hodgkin's Disease

NCT00005595 | Terminated Phase 2 DMC

• 3 other identifiers: NCI 99H5NU-99H5NCI-T99-0093
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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 arsenic trioxide in treating patients who have relapsed or refractory Hodgkin's disease.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Interventions

arsenic trioxide DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory Hodgkin's disease Relapsed after prior first line treatment with at least 2 regimens, such as: Mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) Doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) MOPP/ABV Stanford 5 OR Refractory to a second line regimen, such as: Mesna, ifosfamide, mitoxantrone, and etoposide (MINE) Etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP) High dose chemotherapy and autologous or allogeneic stem cell transplantation At least 1 measurable lesion PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Unless documented bone marrow involvement: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No other prior malignancies within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix No concurrent active infection requiring antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent biologic agents No concurrent monoclonal antibodies No concurrent bone marrow transplantation Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent anticancer agents

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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Martin S. Tallman, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: March 4, 2004
• Study Start: June 1, 2000
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: June 11, 2012

Record last verified: 2012-06

Locations

US (2)