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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DTGM fusion protein
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 17, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003840
Brief Title
DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
Official Title
A Phase I Study of DTGM Fusion Protein (IND BB#8153) in Relapsed and Refractory Adult Acute Myeloid Leukemia (AML)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
DTGM fusion protein

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur E. Frankel, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States

12. IPD Sharing Statement

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

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