DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00003840
First received: November 1, 1999
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

RATIONALE: DTGM fusion protein may be able to locate cancer cells and stop them from growing.

PURPOSE: Phase I/II trial to study the effectiveness of DTGM fusion protein in treating patients who have recurrent or refractory acute myeloid leukemia.


Condition Intervention Phase
Leukemia
Biological: DTGM fusion protein
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of DTGM Fusion Protein (IND BB#8153) in Relapsed and Refractory Adult Acute Myeloid Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Study Start Date: October 2000
Study Completion Date: July 2005
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of DTGM fusion protein in patients with recurrent or refractory adult acute myeloid leukemia. II. Determine the dose-limiting toxic effects of this regimen in these patients. III. Measure the pharmacokinetics of this regimen in these patients. IV. Evaluate the response rate at the maximum tolerated dose and immune responses in patients treated with this regimen. V. Correlate in vitro sensitivity of leukemic blasts to this regimen with the response rate in these patients. VI. Correlate tumor necrosis factor genetic polymorphisms with toxicity profiles and dose-limiting toxic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to serum level of anti-DTGM antibody titer (2 mg/L or less vs greater than 2 mg/L). Patients receive DTGM fusion protein IV over 15 minutes on days 1-5. Patients with a partial response are eligible for retreatment. Cohorts of 3-6 patients receive escalating doses of DTGM fusion protein until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with DTGM fusion protein at the MTD. Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically, morphologically, or cell surface marker confirmed adult acute myeloid leukemia (AML) Recurrent or refractory after at least 1 prior induction therapy OR Relapsed after remission of less than 1 year duration Antecedent myelodysplasia that has evolved to AML allowed Ineligible for allogeneic stem cell transplantation or failed prior transplantation No CNS leukemia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC no greater than 10,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases less than 5 times upper limit of normal Albumin at least 3 g/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% normal No myocardial infarction within the past 6 months No disseminated intravascular coagulation Pulmonary: FEV1 at least 70% normal Other: No uncontrolled infections No other concurrent serious medical problems or psychiatric disorders No prior severe penicillin allergy (hives or anaphylactic reactions) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent growth factors Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Prior hydroxyurea or low-dose cytarabine (less than 100 mg subcutaneously) to lower blast counts allowed if discontinued on day 1 of study therapy No concurrent antineoplastic chemotherapy Endocrine therapy: Concurrent corticosteroids allowed, including antiemetics Radiotherapy: Recovered from prior radiotherapy No concurrent radiotherapy Surgery: Not specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003840

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Arthur E. Frankel, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003840     History of Changes
Other Study ID Numbers: CCCWFU-22300, CDR0000066998, CCCWFU-22198, NCI-H99-0027
Study First Received: November 1, 1999
Last Updated: June 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 20, 2014