Esophageal CancerPhase 1NCT00002625
Topotecan and Radiation Therapy in Treating Patients With Solid Tumors or Lymphoma
A Phase 1 study testing topotecan hydrochloride, low-LET electron therapy and low-LET photon therapy in people with Esophageal Cancer and Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Lung Cancer, Lymphoma
- What is being tested?
- topotecan hydrochloride, low-LET electron therapy and low-LET photon therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1995to Sep 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION
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.
Read the detailed description
OBJECTIVES:
- Define the maximum tolerated dose and safety profile of topotecan (TOPO) administered with daily high-dose thoracic radiotherapy to a total of 60 Gy in patients with solid tumor or lymphoma.
II. Assess the qualitative and quantitative nature of the toxic effects encountered in this treatment.
III. Estimate the tissue and tumor TOPO concentrations during radiotherapy by evaluating plasma TOPO levels.
IV. Evaluate, using Western blot and immunohistochemical stain, the effects of TOPO/radiotherapy on topoisomerase I levels in peripheral blood lymphocytes (PBL).
- Determine whether TOPO induces apoptosis in PBL from this patient population.
VI. Examine tumor tissue pre- and post-treatment (if available) for topoisomerase I levels, DNA damage, topoisomerase I/DNA complexes, and apoptotic events.
OUTLINE:
Radiosensitization plus Radiotherapy. Topotecan, TOPO, NSC-609699; plus external-beam irradiation using linear accelerators with photon energies between 4 and 10 MV (electrons acceptable for the boost field).
- Conditions
- Esophageal Cancer, Lung Cancer, Lymphoma
- Being tested
- topotecan hydrochloride, low-LET electron therapy, low-LET photon therapy
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent non-small cell lung cancer, recurrent adult Hodgkin lymphoma, recurrent esophageal cancer, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent small cell lung cancer, 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
- Medical subject headings
- Esophageal Neoplasms, Lung Neoplasms, Lymphoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Lymphoma, T-Cell, Cutaneous, Small Cell Lung Carcinoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecan hydrochlorideDrug
low-LET electron therapyRadiation
low-LET photon therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: topotecan hydrochloride; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2004 (estimated)
- Study startMar 1995
- Primary completionApr 2000
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- George Wilding, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002625
- Sponsor's protocol ID
- CDR0000063990
- Other IDs
- WCCC-CO-9492, NCI-T94-0099C, CDR0000063990
- Status last verified
- Jan 2013
- First submitted
- 1 Nov 1999
- Last updated
- 11 Feb 2013
- Results posted
- No
Publications
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.
PubMed 15013589
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE I STUDY OF TOPOTECAN AND THORACIC RADIATION
- ClinicalTrials.gov ID
- NCT00002625
- Acronym / sponsor ID
- CDR0000063990
- Conditions
- Esophageal Cancer, Lung Cancer, Lymphoma
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent non-small cell lung cancer, recurrent adult Hodgkin lymphoma, recurrent esophageal cancer, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 1995
- Primary completion
- Apr 2000 (actual)
- Study completion
- Sep 2000 (actual)
- First posted
- 10 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Define the maximum tolerated dose and safety profile of topotecan (TOPO) administered with daily high-dose thoracic radiotherapy to a total of 60 Gy in patients with solid tumor or lymphoma.
II. Assess the qualitative and quantitative nature of the toxic effects encountered in this treatment.
III. Estimate the tissue and tumor TOPO concentrations during radiotherapy by evaluating plasma TOPO levels.
IV. Evaluate, using Western blot and immunohistochemical stain, the effects of TOPO/radiotherapy on topoisomerase I levels in peripheral blood lymphocytes (PBL).
- Determine whether TOPO induces apoptosis in PBL from this patient population.
VI. Examine tumor tissue pre- and post-treatment (if available) for topoisomerase I levels, DNA damage, topoisomerase I/DNA complexes, and apoptotic events.
OUTLINE:
Radiosensitization plus Radiotherapy. Topotecan, TOPO, NSC-609699; plus external-beam irradiation using linear accelerators with photon energies between 4 and 10 MV (electrons acceptable for the boost field).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: topotecan hydrochloride, Radiation: low-LET electron therapy, Radiation: low-LET photon therapyRadiosensitization 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topotecan hydrochloride | Drug | Arm I |
| low-LET electron therapy | Radiation | Arm I |
| low-LET photon therapy | Radiation | Arm I |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
- Results publication: PubMed 15013589Forouzannia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Wilding, MD study chair
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing topotecan hydrochloride, low-LET electron therapy and low-LET photon therapy in people with Esophageal Cancer and Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.