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A Phase I and Pharmacokinetic Study of Sequences of NSC 655649 (Rebeccamycin Analogue) and Cisplatin Without and With Granulocyte Colony-Stimulating Factor Support Every 21 Days


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I and Pharmacokinetic Study of Sequences of NSC 655649 (Rebeccamycin Analogue) and Cisplatin Without and With Granulocyte Colony-Stimulating Factor Support Every 21 Days


OBJECTIVES:

I. Determine the maximum tolerated doses of a rebeccamycin analogue and cisplatin with or
without filgrastim (G-CSF) in patients with advanced malignancies.

II. Determine the qualitative and quantitative toxicities of these regimens in these
patients.

III. Determine if the pharmacokinetics of a rebeccamycin analogue are affected by cisplatin
and if there are sequence dependent pharmacokinetic effects.

IV. Assess any antitumor effects of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study of a rebeccamycin analogue and
cisplatin.

Part I (previously untreated or minimally pretreated patients): The first patient of each
cohort receives cisplatin IV over 1 hour followed 2 hours later by a rebeccamycin analogue
IV over 1 hour on day 1. The second patient in the same cohort receives the same drugs in
the reverse order. The drug sequence for each additional patient within the same cohort is
alternated with reference to the preceding patient. During each subsequent course, the study
drugs are administered to each patient in the reverse order as compared to the prior course.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity.

Dose escalation is initially performed without filgrastim (G-CSF). Cohorts of 4-6 patients
receive escalating doses of a rebeccamycin analogue and cisplatin until the maximum
tolerated dose (MTD) of each drug is determined. The MTD is defined as the highest dose at
which less than 2 of 6 patients experience dose limiting toxicity (DLT). If 2 of the first 6
patients experience DLT, then dose escalation proceeds in combination with G-CSF treatment.
Patients receive G-CSF subcutaneously daily beginning on day 2 and continuing until blood
counts have recovered for 2 days or until approximately day 15. Cohorts of 4-6 patients
receive escalating doses of a rebeccamycin analogue and cisplatin as above. The MTD is
defined as above.

Part II (heavily pretreated patients): Heavily pretreated patients receive a rebeccamycin
analogue and cisplatin starting at 2 dose levels preceding the MTD from part I.

Patients are followed for at least 30 days.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically proven advanced malignancy that is refractory to
prior therapy or unlikely to benefit from standard therapy (e.g., chemotherapy,
radiotherapy, and surgery)

- Part I: Previously untreated OR minimally pretreated

- Ineligible for part I and considered heavily pretreated if:

- Prior radiotherapy to wide ports involving the pelvis or at least 25%
of bone marrow

- Greater than 6 courses of prior combination chemotherapy including
alkylating agent

- Prior nitrosoureas or mitomycin

- Widespread bone metastases with bone marrow involvement by bone marrow
biopsy (positive bilateral bone marrow biopsy for lymphoma patients)

- Part II: Heavily pretreated as defined above

- Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- SWOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm^3

- Hemoglobin greater than 9 mg/dL

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 mg/dL

Renal:

- Creatinine less than 1.5 mg/dL

Cardiovascular:

- No uncontrolled hypertension

- No angina pectoris

- No clinically significant, multifocal, uncontrolled cardiac dysrhythmias

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active serious infection

- No clinically severe peripheral neuropathy (grade 1 or worse)

- No nonmalignant medical condition that would preclude compliance or increase risk of
participation in study

- No hypersensitivity to E. coli derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No other concurrent colony stimulating factors for prophylactic purposes

Chemotherapy:

- At least 3 weeks since prior chemotherapy (6 weeks since prior nitrosoureas and
mitomycin) and recovered

Endocrine therapy:

- No chronic oral corticosteroids

- No concurrent corticosteroids except as prophylactic antiemetic

Radiotherapy:

- At least 3 weeks since prior radiotherapy and recovered

Other:

- At least 1 month since prior investigational agent

- No prophylactic oral or IV antibiotics for neutropenia unless fever present

- No other concurrent anticancer treatment or investigational agent

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Lisa Hammond, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067430

NCT ID:

NCT00004189

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • small intestine lymphoma
  • unspecified adult solid tumor, protocol specific
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • intraocular lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Cancer Therapy and Research CenterSan Antonio, Texas  78229
St. Luke's Lutheran HospitalSan Antonio, Texas  78229