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Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer

Primary Purpose

Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
filgrastim
becatecarin
cisplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center at San Antonio
  • Cancer Therapy and Research Center
  • St. Luke's Lutheran Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

See detailed description.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 21, 2000
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004189
Brief Title
Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase I trial to study the effectiveness of rebeccamycin analog and cisplatin with or without filgrastim in treating patients who have advanced cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
See detailed description.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
becatecarin
Intervention Type
Drug
Intervention Name(s)
cisplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Hammond, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
St. Luke's Lutheran Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer

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