Know Cancer

forgot password

A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors

Phase 1
1 Year
21 Years
Open (Enrolling)
Unspecified Childhood Solid Tumor, Protocol Specific

Thank you

Trial Information

A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors


- Determine the maximum tolerated dose and dose limiting toxicity of vincristine when
administered in combination with irinotecan in children with refractory solid tumors.

- Determine the safe and tolerable phase II dose of this combination regimen in this
patient population.

- Determine the pharmacokinetics of this combination regimen in these patients.

- Determine the incidence and severity of other toxicities of this combination regimen in
these patients.

- Determine preliminary evidence of antitumor activity of this combination regimen in
this patient population.

OUTLINE: This is a dose-escalation study of vincristine.

Patients receive vincristine IV on day 2 of the first course (day 1 of subsequent courses)
and days 8, 15, 22, and 29, and irinotecan IV over 1 hour on days 1-5 and 22-26. Courses
repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients with responsive or stable disease receive additional courses of therapy for a
maximum of 1 year.

Cohorts of 3-6 patients receive escalating doses of vincristine until the maximum tolerated
dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of
3 or 2 of 6 patients experience dose limiting toxicity.

Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study within 1 year.

Inclusion Criteria


- Histologically or cytologically confirmed initial diagnosis of malignant solid tumor
refractory to conventional therapy or for which no effective therapy exists

- Brain tumors allowed if not on anticonvulsants

- Brainstem gliomas allowed without histologic diagnosis

- Solid lymphomas allowed

- No bone marrow involvement



- 1 to 21

Performance status:

- Karnofsky 50-100% if over 10 years of age

- Lansky 50-100% if 10 years of age and under

Life expectancy:

- At least 8 weeks


- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8 g/dL (transfusion allowed)


- Bilirubin no greater than 1.5 mg/dL

- ALT less than 5 times normal

- Albumin at least 2 g/dL


- Creatinine normal for age OR

- Glomerular filtration rate normal for age


- No uncontrolled infection

- No other significant systemic illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- At least 1 week since prior biologic therapy and recovered

- At least 1 week since prior growth factors

- No prior stem cell transplantation


- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)
and recovered

- No more than 2 prior chemotherapy regimens

- No other concurrent cancer chemotherapy

Endocrine therapy:

- Concurrent dexamethasone allowed in patients with CNS tumors provided dose is stable
or decreasing for at least 2 weeks prior to study


- Recovered from prior radiotherapy

- At least 2 weeks since prior local palliative radiotherapy (small port)

- No prior substantial bone marrow radiotherapy

- No prior central axis radiotherapy

- No concurrent radiotherapy


- Not specified


- No concurrent anticonvulsants

- No other concurrent anticancer therapy or investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Cynthia S. Kretschmar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Floating Hospital for Children at Tufts - New England Medical Center


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

Related Keywords:

  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Mount Sinai School of Medicine New York, New York  10029
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
Children's Hospital Medical Center - Cincinnati Cincinnati, Ohio  45229-3039
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105