LymphomaPhase 1NCT00003993
Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
A Phase 1 study testing aldesleukin and bryostatin 1 in people with Lymphoma and Small Intestine Cancer, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- aldesleukin and bryostatin 1
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Jul 2008
- 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:
- Histologically proven solid tumor or lymphoma that is not curable by surgery, radiotherapy, or standard chemotherapy, or for which no curative therapy exists
- Prostate cancer patients must have the following:
- Tumor progression following blockade of both testicular and adrenal androgens
- Serum testosterone in the castrate range (less than 20 ng/mL)
- At least 3 months since prior suramin therapy
- At least 4 weeks since prior flutamide or other antiandrogen medication and no evidence of response to treatment
- Luprolide should continue if no prior orchiectomy
- No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0 or 1
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 3,500/mm^3 OR
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic:
- Hepatitis B surface antigen negative
- PT no greater than 14 seconds
- PTT no greater than 35 seconds
- Bilirubin no greater than 1.5 mg/dL unless due to Gilbert's disease
- SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- Albumin at least 2.5 g/dL
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 50 mL/min
- Corrected calcium at least 8.0 mg/dL, but no greater than 10.7 mg/dL
Cardiovascular:
- No prior myocardial infarction, coronary artery disease (CAD), congestive heart failure, second or third degree AV block, or cardiac arrhythmias requiring treatment
- No evidence of CAD on EKG
Pulmonary:
- FEV1-1 at least 70% predicted
- DLCO at least 60% predicted
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- At least 1 week since active infection requiring antibiotics
- No other medical or psychiatric condition that would preclude study
- No prior or concurrent seizure disorders controlled with medication
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior interleukin-2
- At least 4 weeks since other prior biologic therapy for solid tumors or lymphomas
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior bryostatin 1
- At least 4 weeks since other prior chemotherapy for solid tumors or lymphomas
Endocrine therapy:
- See Disease Characteristics
- At least 4 weeks since other prior endocrine therapy for solid tumors or lymphomas
- No absolute requirement for corticosteroids
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy for solid tumors or lymphomas
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior surgery for solid tumors or lymphomas
Other:
- No absolute requirement for nonsteroidal anti-inflammatory drugs or H2 blockers
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Aging - Baltimore
Baltimore, Maryland, 21224-6825
About this study
Official title: A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin 1 in treating patients with refractory solid tumors or lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients with refractory solid tumors or lymphomas.
- Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these patients.
- Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition and costimulatory molecules on human monocytes and their ability to act as antigen presenting cells.
- Assess any anti-tumor response in these patients treated with this regimen.
OUTLINE: This is a dose escalation study of interleukin-2.
Patients receive bryostatin 1 IV over 24 hours on days 1 and 8, and interleukin-2 subcutaneously on days 1-5 and days 8-12. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of interleukin-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study in less than 2 years.
- Being tested
- aldesleukin, bryostatin 1
- Keywords
- stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, unspecified adult solid tumor, protocol specific, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt 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
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, T-Cell, Cutaneous, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
bryostatin 1Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1999
- Primary completionJul 2008
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.
- 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
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Igor Espinoza-Delgado, MD, Study chair, Gerontology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003993
- Sponsor's protocol ID
- CDR0000067198
- Other IDs
- NCI-T99-0015, LSUMC-9901
- Status last verified
- May 2006
- First submitted
- 1 Nov 1999
- Last updated
- 29 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells
- ClinicalTrials.gov ID
- NCT00003993
- Acronym / sponsor ID
- CDR0000067198
- Keywords
- stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, unspecified adult solid tumor, protocol specific, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1999
- Primary completion
- Jul 2008 (actual)
- First posted
- 27 Jan 2003 (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 cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin 1 in treating patients with refractory solid tumors or lymphoma.
Detailed description
OBJECTIVES:
- Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients with refractory solid tumors or lymphomas.
- Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these patients.
- Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition and costimulatory molecules on human monocytes and their ability to act as antigen presenting cells.
- Assess any anti-tumor response in these patients treated with this regimen.
OUTLINE: This is a dose escalation study of interleukin-2.
Patients receive bryostatin 1 IV over 24 hours on days 1 and 8, and interleukin-2 subcutaneously on days 1-5 and days 8-12. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of interleukin-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study in less than 2 years.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| aldesleukin | Biological | – |
| bryostatin 1 | Drug | – |
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 29 Apr 2015.
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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.
Igor Espinoza-Delgado, MD study chair
Gerontology Research Center
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 aldesleukin and bryostatin 1 in people with Lymphoma and Small Intestine Cancer, run by National Institute on Aging (NIA) 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 29 Apr 2015. 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?
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 29 Apr 2015.