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	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Phase I Pilot Study of IL-6/G-CSF Following Sequential Induction Chemotherapy with IDA/ARA-C, DHAD/VP-16/ARA-C, and High-Dose CTX in Elderly Patients with AML (Summary Last Modified 06/95)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase I Treatment Completed over 60 MSKCC-93134
NCI-V94-0360

Objectives

I.  Assess the safety of and tolerance to interleukin-6/granulocyte colony 
stimulating factor following sequential induction chemotherapy with 
idarubicin/cytarabine, mitoxantrone/etoposide/cytarabine, and high-dose 
cyclophosphamide in elderly patients with AML.

Entry Criteria

Disease Characteristics:


Morphologically and histologically confirmed, newly diagnosed acute
myelogenous leukemia
  Morphologic and histochemical confirmation at MSKCC required

Prior/Concurrent Therapy:


No prior therapy

Patient Characteristics:


Age:
  Over 60

Performance status:
  Karnofsky 30-100%

Hepatic:
  Bilirubin less than 1.5 mg/dl

Renal:
  Creatinine less than 2.0 mg/dl
  No history of glomerulonephritis

Cardiovascular:
  LVEF greater than 50% by MUGA or echocardiogram
  No evidence of ischemia on EKG
  No history of cardiac disease

Other:
  No history of thyroid disease
  No history of Cushing's disease
  No history of autoimmune disease (i.e., rheumatoid arthritis, lupus, Sjogren
     syndrome, psoriasis)
  No history of coagulopathy or thromboembolic disease (unrelated to AML)
  No HIV positivity
  No prior malignancy
  No other life-threatening medical condition unless deemed acceptable by the
     principal investigator

Expected Enrollment

Up to 18 patients will be treated.

Outline

The following acronyms are used:
  ARA-C      Cytarabine, NSC-63878
  CTX        Cyclophosphamide, NSC-26271
  DHAD       Mitoxantrone, NSC-301739
  G-CSF      Granulocyte Colony Stimulating Factor (Amgen),
               NSC-614629
  IDA        Idarubicin, NSC-256439
  IL-6       Interleukin-6 (Sandoz), NSC-643497
  VP-16      Etoposide, NSC-141540

Sequential 2-Drug and 3-Drug Combination Chemotherapy followed by Single-Agent 
Chemotherapy, each with Hematopoietic Stimulation.  COURSE 1:  IDA/ARA-C; with 
G-CSF/IL-6; followed by COURSE 2:  DHAD/VP-16/ARA-C; with G-CSF/IL-6; followed 
by COURSE 3:  CTX; with G-CSF/IL-6.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Peter Maslak, MD, Protocol chair
Ph: 212-639-5518; 800-525-2225
Email: maslakp@mskcc.org

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.