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


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

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Trial Information

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


OBJECTIVES:

- 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


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 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

Hematopoietic:

- 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)

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- ALT less than 5 times normal

- Albumin at least 2 g/dL

Renal:

- Creatinine normal for age OR

- Glomerular filtration rate normal for age

Other:

- No uncontrolled infection

- No other significant systemic illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

- 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

Radiotherapy:

- 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

Surgery:

- Not specified

Other:

- No concurrent anticonvulsants

- No other concurrent anticancer therapy or investigational agents

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000068102

NCT ID:

NCT00006095

Start Date:

July 2000

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Mount Sinai School of MedicineNew York, New York  10029
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105