Leukemia Clinical Trial
Official title:
A Pilot Clinical Trial of Mitomycin C Modulation of Multidrug Resistance Proteins and a Phase I Evaluation of Mitomycin C and Mitoxantrone in Patients With Acute Myelogenous Leukemia
Verified date | June 2000 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining
mitomycin with a chemotherapy drug may reduce resistance to the drug and allow the cancer
cells to be killed.
PURPOSE: Phase I trial to study the effectiveness of mitomycin and mitoxantrone in treating
patients with acute myelogenous leukemia and to determine whether mitomycin can reduce the
cancer's resistance to chemotherapy.
Status | Completed |
Enrollment | 29 |
Est. completion date | August 2000 |
Est. primary completion date | August 2000 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: Acute myelogenous leukemia, either de novo or secondary (evolving
from myelodysplastic syndrome, myeloproliferative syndrome, or previous treatment for
malignancies other than leukemia) OR Refractory anemia with excess blasts in transformation
Patient is at least 60 years old and at least one of the following is true: Failed one
induction attempt or First or greater relapse OR Patient is 18-59 years old without an
acceptable allogeneic donor and no autologous marrow for transplant and at least one of the
following is true: Failed 2 separate induction attempts, or Second or greater relapse, or
Resistant relapse, or Relapsed post transplant Prior treatment with anthracyclines or
mitoxantrone required Cumulative daunorubicin dose less than 400/m2 required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70%-100% (50% if hospitalized) Hematopoietic: Not specified Hepatic: Total direct bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 3 x normal Alkaline phosphatase no greater than 3 x normal No active hepatitis Renal: Not specified Cardiovascular: No myocardial infarction within last 6 months No congestive heart failure Ejection fraction greater than 50% (measured by MUGA or 2-D Echo) Pulmonary: No severe chronic obstructive pulmonary disease Other: No active infection or antimicrobiologically stabilized infection Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified |
Country | Name | City | State |
---|---|---|---|
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | National Cancer Institute (NCI) |
United States,
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