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AIDS-related Diffuse Large Cell LymphomaPhase 1NCT00022555

Bryostatin 1 Plus Vincristine in Treating Patients With Recurrent or Refractory HIV-Related Lymphoma

A Phase 1 study testing bryostatin 1 and vincristine sulfate in people with AIDS-related Diffuse Large Cell Lymphoma and AIDS-related Diffuse Mixed Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase I trial to study the effectiveness of bryostatin 1 plus vincristine in treating patients who have recurrent or refractory 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?
Ages 18 years and older
What is being tested?
bryostatin 1 and vincristine sulfate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Nov 2001to Jul 2003
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

Who may be able to join

  • Histologically confirmed B-cell lymphoma
  • Eligible subtypes:
  • Intermediate or high-grade non-Hodgkin's lymphoma (NHL), defined as follicular large cell, mantle cell, diffuse mixed cell, diffuse large cell and variants, Burkitt or Burkitt-like, or unclassifiable aggressive histologies
  • Body cavity-based lymphoma or primary effusion lymphoma
  • Evidence of HIV infection
  • Received at least 1 prior systemic chemotherapy regimen with failure to respond or relapse after completion of first-line therapy, including one of the following doxorubicin-based combinations:
Show all 47Show fewer
  • Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)
  • Infusional cyclophosphamide, doxorubicin, and etoposide (CDE)
  • Etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH)
  • Evaluable disease outside of prior radiation port
  • No CNS parenchymal or leptomeningeal involvement
  • No primary CNS NHL
  • No HTLV-1-associated leukemia or lymphoma
  • Performance status - Karnofsky 70-100%
  • At least 12 weeks
  • Absolute granulocyte count at least 1,000/mm3
  • Platelet count at least 75,000/mm3
  • Hemoglobin at least 8.0 g/dL
  • Bilirubin no greater than 1.5 mg/dL (unless concurrently on indinavir)
  • SGOT and SGPT less than 3 times upper limit of normal
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 50 mL/min
  • No history of cardiac disease
  • LVEF at least 45% by radionuclide ventriculography
  • No symptomatic congestive heart failure
  • No active angina pectoris
  • No uncontrolled hypertension
  • No history of symptomatic pulmonary disease
  • Corrected DLCO more than 50% predicted
  • No severe chronic obstructive lung disease
  • No symptomatic restrictive lung disease
  • Recurrent controllable infection (e.g., thrush) on chronic suppressive therapy allowed
  • No active uncontrolled infection
  • No active significant opportunistic infection (e.g., acute Pneumocystis pneumonia, cytomegalovirus retinitis on induction or maintenance therapy, acute toxoplasmosis)
  • No grade 2 or greater peripheral neuropathy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • At least 24 hours since prior transfusion
  • At least 24 hours since prior colony-stimulating factor therapy
  • No concurrent prophylactic filgrastim (G-CSF)
  • See Disease Characteristics
  • No concurrent hydroxyurea
  • See Disease Characteristics
  • At least 4 weeks since prior large-field radiotherapy
  • At least 3 weeks since prior anticancer therapy and recovered
  • Must be receiving stable antiretroviral regimen of at least 4 weeks duration

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AIDS - Associated Malignancies Clinical Trials Consortium

    Rockville, Maryland, 20850

Other trials in United States

About this study

Official title: A Phase I Trial of Combination Bryostatin-1 and Vincristine in HIV-Related B-cell Neoplasms

Phase I trial to study the effectiveness of bryostatin 1 plus vincristine in treating patients who have recurrent or refractory lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bryostatin 1 may help vincristine kill more cancer cells by making them more sensitive to the drug

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose of bryostatin 1 when administered with vincristine in patients with recurrent or refractory HIV-related B-cell lymphoma.

II. Determine the toxicity profile of this regimen in these patients. III. Determine the objective response and survival of these patients treated with this regimen.

IV. Determine the immunomodulatory effects of this regimen on interleukin-2 (IL-2), IL-2 receptor, and IL-6 cytokine levels in these patients.

  1. Determine the effect of this regimen on CD4+ lymphocyte count and HIV load in these patients.

VI. Determine the effect of this regimen on the human herpes virus-8 load in these patients with body cavity-based lymphoma.

OUTLINE: This is a multicenter, dose-escalation study of bryostatin 1.

Patients receive bryostatin 1 IV continuously on days 1 and 15 and vincristine IV over 5 minutes on days 2 and 16. Treatment continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bryostatin 1 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.

Being tested
bryostatin 1, vincristine sulfate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bryostatin 1Drug

    Also called B705008K112, BRYO, Bryostatin

    Given IV

  • vincristine sulfateDrug

    Also called leurocristine sulfate, VCR, Vincasar PFS

    Given IV

Study groups in NCT00022555
Study groupRoleWhat they receive
Treatment (bryostatin 1, vincristine sulfate)ExperimentalPatients receive bryostatin 1 IV continuously on days 1 and 15 and vincristine IV over 5 minutes on days 2 and 16. Treatment continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: bryostatin 1; Drug: vincristine sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of bryostatin-1 defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity

    Measured: 4 weeks

Secondary outcomes (2)

  1. Dose-limiting toxicities

    Defined as any >= grade 2 neuropathy, other grade 3 non-hematologic toxicity (excluding alopecia and grade 3 nausea and vomiting that is responsive to standard pharmacologic intervention) or grade 4 hematologic toxicity in 2 or more patients. The incidence of toxicity related dose reduction and treatment discontinuation will be summarized for each dose group.

    Measured: 4 weeks

  2. Immunomodulatory effects of this combination

    Measured by a solid phase Enzyme Amplified Sensitivity Immunoassay.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 2001
  3. Primary completionJul 2003

Resources

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022555
Sponsor's protocol ID
NCI-2012-02398
Other IDs
AMC-029, U01CA070019, CDR0000068830
Status last verified
Jan 2013
First submitted
10 Aug 2001
Last updated
25 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing bryostatin 1 and vincristine sulfate in people with AIDS-related Diffuse Large Cell Lymphoma and AIDS-related Diffuse Mixed Cell 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.

Who may be eligible to take part?

The sponsor lists 47 inclusion and 0 exclusion criteria. 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 25 Jan 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.

What does the primary outcome measure?

MTD of bryostatin-1 defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (time frame: 4 weeks). 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 NCT00022555.

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 25 Jan 2013.

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