Lung CancerPhase 2NCT00005849
Bryostatin 1 Plus Paclitaxel in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer
A Phase 2 study testing bryostatin 1 and paclitaxel in people with Lung Cancer, run by University of Chicago at 10 sites in United States.
Trial summary
RATIONALE: 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. PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in treating patients who have stage IIIB, stage IV, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- bryostatin 1 and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2000to Nov 2003
- Phase
- Phase 2
- 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: Histologically or cytologically proven stage IIIB, IV or recurrent non-small cell lung cancer (NSCLC) Patients with stage IIIB disease must have pleural effusion Measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT less than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Blood urea nitrogen less than 1.5 times normal Cardiovascular: No symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months No heart block worse than first degree, bundle branch block, or ventricular or supraventricular arrhythmia by 12 lead electrocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled concurrent illness including, but not limited to, ongoing or active infection
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony-stimulating factors Chemotherapy: No prior chemotherapy for NSCLC Endocrine therapy: Not specified Radiotherapy: Greater than 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART) in HIV positive patients
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
Evanston Northwestern Health Care
Evanston, Illinois, 60201
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46885-5099
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
About this study
Official title: Phase II Study of Bryostatin-1 in Combination With Paclitaxel for Non-Small Cell Lung Cancer
RATIONALE: 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.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Determine the overall, partial, and complete response rates in patients with stage IIIB-IV or recurrent non-small cell lung cancer treated with bryostatin 1 and paclitaxel. II. Determine the overall survival and time to tumor progression in patients treated with this regimen. III. Determine the T cell subset analysis and serum levels of interleukin-6 and tumor necrosis factor alpha in these patients after receiving bryostatin 1 and correlate with clinical endpoints.
OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 2 years for survival.
PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 1 year.
- Conditions
- Lung Cancer
- Being tested
- bryostatin 1, paclitaxel
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bryostatin 1Drug
paclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Paclitaxel (90 mg/m2, days 1, 8 and 15 of every 28 day cycle), Bryostatin-1 (50 mcg/m2, days 2, 9 and 16 of every 28 day cycle) Receives: Drug: bryostatin 1; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2004 (estimated)
- Study startApr 2000
- Primary completionSep 2002
- Study completionNov 2003
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ann M. Mauer, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005849
- Sponsor's protocol ID
- 10337
- Other IDs
- UCCRC-10337, NCI-T99-0018
- Status last verified
- Feb 2013
- First submitted
- 2 Jun 2000
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Winegarden JD, Mauer AM, Gajewski TF, Hoffman PC, Krauss S, Rudin CM, Vokes EE. A phase II study of bryostatin-1 and paclitaxel in patients with advanced non-small cell lung cancer. Lung Cancer. 2003 Feb;39(2):191-6. doi: 10.1016/s0169-5002(02)00447-6.
PubMed 12581572
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 II Study of Bryostatin-1 in Combination With Paclitaxel for Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00005849
- Acronym / sponsor ID
- 10337
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2000
- Primary completion
- Sep 2002 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 26 Apr 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.
RATIONALE: 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.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Detailed description
OBJECTIVES: I. Determine the overall, partial, and complete response rates in patients with stage IIIB-IV or recurrent non-small cell lung cancer treated with bryostatin 1 and paclitaxel. II. Determine the overall survival and time to tumor progression in patients treated with this regimen. III. Determine the T cell subset analysis and serum levels of interleukin-6 and tumor necrosis factor alpha in these patients after receiving bryostatin 1 and correlate with clinical endpoints.
OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 2 years for survival.
PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: bryostatin 1, Drug: paclitaxelPaclitaxel (90 mg/m2, days 1, 8 and 15 of every 28 day cycle), Bryostatin-1 (50 mcg/m2, days 2, 9 and 16 of every 28 day cycle) |
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 |
|---|---|---|
| bryostatin 1 | Drug | Arm A |
| paclitaxel | Drug | Arm A |
Primary outcome
Clinical response rate
Time frame: 3 years
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 12581572Winegarden JD, Mauer AM, Gajewski TF, Hoffman PC, Krauss S, Rudin CM, Vokes EE. A phase II study of bryostatin-1 and paclitaxel in patients with advanced non-small cell lung cancer. Lung Cancer. 2003 Feb;39(2):191-6. doi: 10.1016/s0169-5002(02)00447-6.
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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.
Ann M. Mauer, MD study chair
University of Chicago
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bryostatin 1 and paclitaxel in people with Lung Cancer, run by University of Chicago at 10 sites 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 10 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Clinical response rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005849, 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.