Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Pharmaceutical / Industry VION-CLI-033

Objectives

1. Determine the complete response rate to VNP40101M in patients with acute myelogenous leukemia or high-risk myelodysplasia .
2. Determine the toxic effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed diagnosis of 1 of the following:
  • Acute myelogenous leukemia
    • Less than 60 years of age and meeting the following criteria:
      • In first relapse after first treatment-induced complete remission (CR)
        • Duration of first CR less than 12 months
        • No prior treatment for first relapse except hydroxyurea
    • 60 years of age and over and meeting 1 of the following criteria:
      • In first relapse after first treatment-induced CR
        • No prior treatment for first relapse except hydroxyurea
          • Prior low-dose, single-agent cytarabine, decitabine, or azacitidine not considered prior cytotoxic chemotherapy
        • Duration of first CR < 12 months
      • No prior treatment with a standard induction regimen containing cytotoxic agents
  • High-risk myelodysplasia, meeting the following criteria:
    • 60 years of age and over
    • No prior cytotoxic chemotherapy except hydroxyurea
      • Prior low-dose, single-agent cytarabine, decitabine, or azacitidine not considered prior cytotoxic chemotherapy
    • High risk defined as International Prognostic Scoring System score ≥ 1.5, defined by cytogenetics, % marrow blasts, and lineage cytopenias

Prior/Concurrent Therapy:

Biologic therapy

• Up to 4 leukapheresis procedures allowed during the first 15 days of study treatment

Chemotherapy

• See Disease Characteristics
• Concurrent additional hydroxyurea (maximum dose of 5 g daily for up to 4 days) allowed between days 4 and 15 of each study course to control elevated blast levels

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Recovered from all prior therapy
• At least 72 hours since prior anti-leukemic treatment with a non-cytotoxic agent
• No concurrent disulfiram (Antabuse)
• No other concurrent anticancer drugs except anagrelide within the first 15 days of study treatment to control elevated platelet counts
• No other concurrent treatment for leukemia, except hydroxyurea used during study treatment
• No other concurrent investigational drugs

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 2.0 mg/dL
• ALT or AST ≤ 5 times upper limit of normal
• Chronic hepatitis allowed

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 3 months
• No symptomatic coronary artery disease
• No uncontrolled arrhythmias
• No uncontrolled congestive heart failure
• No other active heart disease

Other

• No uncontrolled active infection
• Not pregnant or nursing
• Fertile patients must use effective contraception

Projected Accrual

A total of 76-230 patients (33-100 with acute myelogenous leukemia (AML) or high-risk myelodysplasia and 43-130 with AML in first relapse) will be accrued for this study within 12-18 months.

Outline

This is an open-label, multicenter study.

Patients receive VNP40101M IV over 30 minutes once on day 1 and oral hydroxyurea every 12 hours on days 1-3 for a total of 6 doses (course 1).

Four to five weeks after the first course, patients undergo bone marrow aspiration and biopsy. If the bone marrow is improved but contains residual leukemia, patients receive a second course of VNP40101M (at the same dose as in course 1) and hydroxyurea (at the same dose as in course 1). If patients achieve complete response (CR), or partial CR after the first or second course, a consolidation course may be given comprising VNP40101M at a reduced dose in combination with hydroxyurea at the same dose as in course 1.

Patients are followed monthly for 6 months, every 2 months for 12 months, and then every 3 months for 18 months .

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

Vion Pharmaceuticals, Inc.

Francis Giles, MD, Protocol chair		Ph: 713-792-7305; 800-392-1611 Email: fgiles@mdanderson.org

U.S.A.
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Syed Fazl Ali Bilgrami, MD	Ph:  860-714-4680
			Email: sbilgram@stfranciscare.org
Indiana
	Indianapolis
	Indiana Oncology Hematology Consultants
		Cathy Spears, RN	Ph:  317-833-1297
		Khuda Khan, MD, PhD	Ph:  317-833-1297
		Maureen Cooper, MD	Ph:  317-833-1297
			Email: coop716@aol.com
New York
	New York
	New York Weill Cornell Cancer Center at Cornell University
		Eric Feldman, MD	Ph:  212-746-5013
North Carolina
	Durham
	Duke Comprehensive Cancer Center
		David Rizzieri, MD	Ph:  919-668-1040
Texas
	Houston
	University of Texas - MD Anderson Cancer Center
		Francis Giles, MD	Ph:  713-792-7305 800-392-1611
			Email: fgiles@mdanderson.org
Belgium
	Brussels
	Cliniques Universitaires Saint-Luc
		Augustin Ferrant, MD, PhD	Ph:  32-2-764-1880
			Email: ferrant@sang.ucl.ac.be
	Leuven
	U.Z. Gasthuisberg
		G.E.G. Verhoef, MD, PhD	Ph:  32-1-634-6886
			Email: gregor.verhoef@uz.kuleuven.ac.be
United Kingdom
England
	London
	King's College Hospital
		Ghulam Mufti	Ph:  44-20-7346-3080
			Email: ghulam.mufti@kcl.ac.uk

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