LymphomaPhase 2NCT00002725
Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
A Phase 2 study testing bryostatin 1 and chemotherapy in people with Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma
- What is being tested?
- bryostatin 1 and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1996to Apr 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed non-Hodgkin's lymphoma
- Working formulation low-, intermediate-, and high-grade histologies eligible
- Mantle cell and marginal zone lymphoma eligible
- Relapse after at least 1 doxorubicin-containing regimen required
- No more than 2 prior chemotherapy regimens
- One prior biologic therapy in addition to the 2 prior chemotherapy regimens allowed
- No prior bone marrow transplantation
- Ineligible for treatment on higher priority protocols
- Patients eligible for bone marrow transplantation may be treated to reduce tumor bulk
- Bidimensionally measurable disease required
- No history of primary or metastatic CNS disease
PATIENT CHARACTERISTICS:
- Age: Any age
- Performance status: Zubrod 0-2
- Life expectancy: Greater than 12 weeks
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 100,000/mm3
- Bilirubin no greater than 1.8 mg/dL
- Transaminases no greater than 2.5 times normal
- Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 70 mL/min
- No HIV antibody
- No serious intercurrent illness
- No pregnant or nursing women
- Effective contraception required of fertile patients throughout study and for 1 year thereafter
PRIOR CONCURRENT THERAPY:
-At least 4 weeks since prior therapy (6 weeks since mitomycin) and recovered
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA
Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
Read the detailed description
OBJECTIVES:
- Determine the response to bryostatin 1 (BRYO) administered weekly for 3 weeks in patients with relapsed non-Hodgkin's lymphoma.
II. Assess the toxic effects of this treatment. III. Establish the correlation between PKC isoenzyme activity and BRYO function in lymphoma cells and normal lymphocytes.
IV. Determine the pharmacokinetic profile of BRYO and its relationship to pharmacodynamics.
OUTLINE:
Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.
- Conditions
- Lymphoma
- Being tested
- bryostatin 1, chemotherapy
- Keywords
- recurrent small lymphocytic 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, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
- Medical subject headings
- Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bryostatin 1Drug
chemotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555. Receives: Drug: bryostatin 1; Drug: chemotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2004 (estimated)
- Study startAug 1996
- Primary completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jorge E. Romaguera, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002725
- Sponsor's protocol ID
- NCI-2012-02239
- Other IDs
- MDA-DM-95061, NCI-T95-0035D, CDR0000064591
- Status last verified
- Oct 2000
- First submitted
- 1 Nov 1999
- Last updated
- 5 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA
- ClinicalTrials.gov ID
- NCT00002725
- Acronym / sponsor ID
- NCI-2012-02239
- Conditions
- Lymphoma
- Keywords
- recurrent small lymphocytic 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 1996
- Primary completion
- Apr 2000 (actual)
- First posted
- 23 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 II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
Detailed description
OBJECTIVES:
- Determine the response to bryostatin 1 (BRYO) administered weekly for 3 weeks in patients with relapsed non-Hodgkin's lymphoma.
II. Assess the toxic effects of this treatment. III. Establish the correlation between PKC isoenzyme activity and BRYO function in lymphoma cells and normal lymphocytes.
IV. Determine the pharmacokinetic profile of BRYO and its relationship to pharmacodynamics.
OUTLINE:
Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.
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: bryostatin 1, Drug: chemotherapySingle-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 I |
| chemotherapy | Drug | 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 5 Feb 2013.
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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.
Jorge E. Romaguera, MD study chair
M.D. Anderson Cancer Center
1 site 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 chemotherapy in people with Lymphoma, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 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 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.
Where can I read the original study information?
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 5 Feb 2013.