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

June 7, 2012 updated by: Northwestern University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

April 1, 2002

Study Completion (Actual)

April 1, 2002

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

March 3, 2004

First Posted (Estimate)

March 4, 2004

Study Record Updates

Last Update Posted (Estimate)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 7, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI 99H5
  • NU-99H5
  • NCI-T99-0093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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