NCT00002625

Brief Summary

Phase I trial to study the effectiveness of topotecan and radiation therapy in treating patients who have solid tumors or lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 1995

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

March 1, 1995

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

June 10, 2004

Completed
Last Updated

February 11, 2013

Status Verified

January 1, 2013

Enrollment Period

5.1 years

First QC Date

November 1, 1999

Last Update Submit

February 8, 2013

Conditions

Esophageal CancerLung CancerLymphoma

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent non-small cell lung cancerrecurrent adult Hodgkin lymphomarecurrent esophageal cancerstage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent small cell lung cancerstage 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/lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomarecurrent 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

Radiosensitization plus Radiotherapy. Topotecan hydrochloride, TOPO, NSC-609699; plus external-beam irradiation using linear accelerators with photon energies between 4 and 10 MV (electrons acceptable for the boost field).

Drug: topotecan hydrochlorideRadiation: low-LET electron therapyRadiation: low-LET photon therapy

Interventions

topotecan hydrochlorideDRUG
Arm I
low-LET electron therapyRADIATION
Arm I
low-LET photon therapyRADIATION
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Microscopically confirmed solid tumor or lymphoma not potentially curable by conventional surgery or radiotherapy * Previously unirradiated disease scheduled to receive thoracic irradiation of up to 60 Gy, including pulmonary and esophageal tumors * No metastatic disease more effectively treated by systemic chemotherapy * No history of brain metastases PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0 or 1 * WBC at least 4,000 * ANC at least 1,500 * Platelets at least 100,000 * Bilirubin no greater than 1.5 mg/dL * Creatinine no greater than 1.5 mg/dL * Calcium no greater than 11.0 mg/dL * No pregnant or nursing women * Pregnancy test required, as appropriate * Effective contraception required of fertile patient PRIOR CONCURRENT THERAPY: * At least 4 weeks since chemotherapy (6 weeks since nitrosoureas and mitomycin) and recovered * At least 4 weeks since radiotherapy and recovered

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

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • Forouzannia A, Schiller J, Berlin J, Hutson P, Boothman D, Storer B, Wilding G, Mehta M. A phase I study of Topotecan, as a radiosensitizer, for thoracic malignancies. Lung Cancer. 2004 Apr;44(1):111-9. doi: 10.1016/j.lungcan.2003.10.005.

    PMID: 15013589RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsLung NeoplasmsLymphomaHodgkin DiseaseCarcinoma, Non-Small-Cell LungLymphoma, T-Cell, CutaneousSmall Cell Lung CarcinomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLymphoma, T-CellLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • George Wilding, MD

    University of Wisconsin, Madison

    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

November 1, 1999

First Posted

June 10, 2004

Study Start

March 1, 1995

Primary Completion

April 1, 2000

Study Completion

September 1, 2000

Last Updated

February 11, 2013

Record last verified: 2013-01

Locations

US(1)