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A Phase I Study of DTGM Fusion Protein (IND BB#8153) in Relapsed and Refractory Adult Acute Myeloid Leukemia (AML)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A Phase I Study of DTGM Fusion Protein (IND BB#8153) in Relapsed and Refractory Adult Acute Myeloid Leukemia (AML)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Arthur E. Frankel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CCCWFU-22300

NCT ID:

NCT00003840

Start Date:

October 2000

Completion Date:

July 2005

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • secondary acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082