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

Lymphoma Clinical Trial

Official title:

Multicenter Phase II Trial of Arsenic Trioxide in Relapsed and Refractory Hodgkin's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005595
• Other study ID #: NCI 99H5
• Secondary ID: NU-99H5NCI-T99-0
• Status: Terminated
• Phase: Phase 2
• First received: May 2, 2000
• Last updated: June 7, 2012
• Start date: June 2000
• Est. completion date: April 2002

Study information

• Verified date: June 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES: I. Determine the efficacy of arsenic trioxide in terms of rate of response (complete or partial remission), duration of response, relapse free survival, and overall survival in patients with relapsed or refractory Hodgkin's disease. II. Evaluate the toxicities of this agent in this patient population. III. Elucidate the mechanism of action of this treatment by measuring induction of apoptosis and caspace activation when given to these patients.

OUTLINE: This is a multicenter study. Patients receive arsenic trioxide IV over 1-2 hours daily for up to 60 days. After 4-6 weeks of rest, patients receive up to 5 additional courses of therapy of 25 days each followed by 4-6 weeks of rest. Patients with a complete response (CR) receive 1 additional course of 25 days after achieving CR. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for 12 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• arsenic trioxide

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,