Bryostatin 1 and Interleukin-2 in Treating Patients With... | NCT00003993 | Trialant
NCT00003993
Sponsor
National Institute on Aging (NIA)
Status
Completed
Last Update Posted
Apr 29, 2015Estimated
Enrollment
24Estimated
Phase
Phase 1
Conditions
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
aldesleukin
bryostatin 1
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00003993
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000067198
Secondary IDs
ID
Type
Description
Link
NCI-T99-0015
LSUMC-9901
Brief Title
Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
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
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
May 2006
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Sep 1999
Primary Completion Date
Jul 2008Actual
Completion Date
Not provided
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 28, 2015
Last Update Posted Date
Apr 29, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Institute on Aging (NIA)NIH
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief 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.
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.
Conditions Module
Conditions
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
24Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
aldesleukin
Biological
bryostatin 1
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Igor Espinoza-Delgado, MD
Gerontology Research Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
National Institute on Aging - Baltimore
Baltimore
Maryland
21224-6825
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D008223
Lymphoma
D006689
Hodgkin Disease
D016410
Lymphoma, T-Cell, Cutaneous
D008224
Lymphoma, Follicular
D008228
Lymphoma, Non-Hodgkin
D016403
Lymphoma, Large B-Cell, Diffuse
D016400
Lymphoma, Large-Cell, Immunoblastic
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D002051
Burkitt Lymphoma
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D064090
Intraocular Lymphoma
D020522
Lymphoma, Mantle-Cell
D007119
Immunoblastic Lymphadenopathy
D017728
Lymphoma, Large-Cell, Anaplastic
D009182
Mycosis Fungoides
D012751
Sezary Syndrome
D018442
Lymphoma, B-Cell, Marginal Zone
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C082598
aldesleukin
C046785
bryostatin 1
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
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
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
primary central nervous system non-Hodgkin lymphoma
intraocular lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
stage IV mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue