NCT00004189

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 lymphoma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Last Updated

February 11, 2013

Status Verified

September 1, 2003

Enrollment Period

3.8 years

First QC Date

January 21, 2000

Last Update Submit

February 8, 2013

Conditions

LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomasmall intestine lymphomaunspecified adult solid tumor, protocol specificstage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaprimary central nervous system non-Hodgkin lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaintraocular lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Study Arms (1)

Arm I

EXPERIMENTAL

See detailed description.

Biological: filgrastimDrug: becatecarinDrug: cisplatin

Interventions

filgrastimBIOLOGICAL
Arm I
becatecarinDRUG
Arm I
cisplatinDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

St. Luke's Lutheran Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

FilgrastimbecatecarinCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteLymphadenopathyLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Lisa Hammond, MD

    The University of Texas Health Science Center at San Antonio

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2000

First Posted

January 27, 2003

Study Start

October 1, 1999

Primary Completion

July 1, 2003

Last Updated

February 11, 2013

Record last verified: 2003-09

Locations

US(3)