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

Phase 2
16 Years
Not Enrolling

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Trial Information

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Martin S. Tallman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NCI 99H5



Start Date:

June 2000

Completion Date:

April 2002

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



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