Study of DT388GMCSF Fusion Protein in Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML)

NCT00074750 | Terminated Phase 1 DMC

• 1 other identifier: DM03-0130
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

DTGM belongs to a new generation of drugs designed to target leukemic cells. To achieve this, DTGM takes advantage of the ability of naturally-produced growth factor (GM, granulocyte-macrophage stimulating factor) to deliver a drug (diphtheria toxin) to cells; preferably leukemic cells. It then attaches to the cells and allows the toxin to enter the leukemic cells and destroy them.

Conditions

Acute Myelogenous Leukemia; Chronic Myelomonocytic Leukemia

Keywords

AML; CMML

Study Arms (1)

DTGM

EXPERIMENTAL

Starting dose of DTGM fusion protein 2 mcg/kg/day as a short (30 min) intravenous infusion, three times /week (M,W,F) for two consecutive weeks. In absence of defined grade 3/4 nonhematological toxicities in the first 0/3 or 1/6 patients, the dose will be escalated by 1 mcg/kg/day for the next patient cohort.

Drug: DTGM

Interventions

DTGM DRUG

Starting dose: 2 mcg/kg by vein three times a week (M,W,F) for two consecutive weeks.

Also known as: Diphtheria toxin fused with granulocyte macrophage colony stimulating factor

DTGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with refractory or relapsed AML ( marrow blasts \> 20% ), must have failed induction therapy or have relapsed after CR duration \< 6 months following induction therapy, untreated or refractory to salvage chemotherapy. Relapsed AML patients with CR duration \> 6 months or previously untreated patients refusing chemotherapy and not considered for treatments of higher priority are also eligible.
• Patients with chronic myelomonocytic leukemia (CMML) who failed at least one course of chemo- or biological therapy( including trial of erythropoietin), or patients with relapsed CMML. Previously untreated CMML patients with HB \< or = 12 g / dL, not eligible for protocols of higher priority or not wishing to receive chemotherapy.
• Patients must have an ECOG performance status of \< 2.
• Patients must have WBC count \< 10,000/mL prior to initiating the treatment. The WBC count must be stabilized below this level for at least three days by leukopheresis or hydroxyurea. Hydroxyurea must be discontinued one day prior to initiation of DT388GMCSF treatment.
• Patients must have creatinine \< 1.6 times ULN: bilirubin \<1.6 times ULN; SGPT \< 2.6 x ULN; albumin \> 3 gm/dl; adequate cardiac function (EF \>44%), oxygen saturation \> 92% without exogenous oxygen administered.
• Patients must be willing to be treated at M D Anderson Cancer Center.
• Women of childbearing potential and men must agree to practice contraception using approved methods.
• No chemotherapy except Hydroxyurea 2 weeks prior to entering the study and recovered from previous toxicity.
• Patients must be \> 17 years old.

You may not qualify if:

• Patients with serious concurrent medical problems. Patients with proven bacterial infections are not eligible until the resolution of the infection (patient afebrile who completed antibacterial therapy, not on steroids). Patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and fever does not exceed 38C for at least 2 days.
• Inability to give informed consent because of psychiatric problems or other serious medical problems.
• Pregnant or nursing women.
• Patients with documented CNS leukemia or leukemia with CNS symptoms.
• Patients who have had a myocardial infarction within the past six months.
• Patients with severe penicillin allergy (anaphylaxis).
• Not fully recovered from toxic effects of prior chemotherapy or radiation therapy.
• Patients who are on corticosteroid treatment for any medical condition.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Wake Forest University: collaborator

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson Cancer Center's website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Chronic

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Miloslav Beran, MD, PhD, DVM

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2003
• First Posted: December 23, 2003
• Study Start: December 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (1)