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LymphomaPhase 3NCT00324831

GM-CSF With or Without Vaccine Therapy After Combination Chemotherapy and Rituximab as First-Line Therapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

A Phase 3 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Favrille at 2 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
autologous immunoglobulin idiotype-KLH conjugate vaccine, cyclophosphamide and doxorubicin hydrochloride
Type of treatment
Vaccines, Surgery or procedure
How many people
480 participants
Where
2 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 3
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 confirmed diffuse large B-cell lymphoma
  • Bulky stage II or stage III or IV disease
  • Treatment naïve
  • International Prognostic Index score of 3 (high-intermediate) or 4/5 (high)
  • Lymphoma accessible for sampling or existing biopsy material judged suitable for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId®)
  • No history of CNS lymphoma or meningeal lymphomatosis
  • No history of indolent lymphoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Platelet count > 75,000/mm^3
  • ALT and AST < 2 times upper limit of normal
  • Not pregnant or nursing
  • No history of unresolved hepatitis B viral infection
  • No history of a treated prior malignancy unless in remission ≥ 2 years, except for treated nonmelanoma carcinomas of the skin or in situ cervical carcinomas or prostatic carcinomas
  • No contraindication to doxorubicin hydrochloride (e.g., abnormal contractility on ECG)
  • No contraindication to vincristine (e.g., peripheral neuropathy)
  • No know HIV positivity
  • No serious nonmalignant disease, including any of the following:
  • Psychiatric disorders
  • Compromised pulmonary function
  • Congestive heart failure
  • Active bacterial, viral, or fungal infections

PRIOR CONCURRENT THERAPY:

  • No prior keyhole limpet hemocyanin
  • No planned radiotherapy during or after study therapy
  • No concurrent systemic immunosuppressive therapy (e.g., steroids)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

Other trials in United States

About this study

Official title: Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of FavID® (Id/KLH) and GM-CSF Following CHOP/Rituximab as First-Line Therapy in Subjects With High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. It is not yet known whether giving GM-CSF together with vaccine therapy is more effective than giving GM-CSF together with a placebo when given after combination chemotherapy and rituximab in treating diffuse large B-cell lymphoma.

PURPOSE: This randomized phase III trial is studying GM-CSF and vaccine therapy to see how well they work compared to GM-CSF and placebo when given after combination chemotherapy and rituximab as first-line therapy in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the 3-year disease-free survival of patients with high-intermediate- or high-risk bulky stage II or stage III or IV diffuse large B-cell lymphoma treated with sargramostim (GM-CSF) with or without autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId®) after combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (CHOP-R).

Secondary

  • Compare the 2-year disease-free survival, duration of response, time to progression, overall survival, and safety in patients treated with these regimens.
  • Estimate the rate of immune reactivity to FavId®.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to risk score (3 [high-intermediate] vs 4 or 5 [high]).

  • Chemotherapy: Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV, vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
  • Sargramostim (GM-CSF) with or without autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId®): Patients achieving complete remission (CR) or unconfirmed CR after chemotherapy and who have FavId® available are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive FavId® vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4.
  • Arm II: Patients receive placebo SC on day 1 and GM-CSF SC as in arm I. In both arms, treatment repeats once a month for 6 months and then once every 2 months for 24 months (18 total vaccinations) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study.

Conditions
Lymphoma
Being tested
autologous immunoglobulin idiotype-KLH conjugate vaccine, cyclophosphamide, doxorubicin hydrochloride, prednisone, rituximab
Keywords
contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • autologous immunoglobulin idiotype-KLH conjugate vaccineDrug

  • cyclophosphamideDrug

  • doxorubicin hydrochlorideDrug

  • prednisoneDrug

  • rituximabDrug

  • sargramostimDrug

  • vincristineDrug

  • Intervention/procedureProcedure or surgery

  • antibody therapyProcedure or surgery

  • biological therapyProcedure or surgery

  • chemotherapyProcedure or surgery

  • colony-stimulating factor therapyProcedure or surgery

  • cytokine therapyProcedure or surgery

  • monoclonal antibody therapyProcedure or surgery

  • non-specific immune-modulator therapyProcedure or surgery

  • therapeutic procedureProcedure or surgery

  • tumor cell derivative vaccineProcedure or surgery

  • vaccine therapyProcedure or surgery

What is being measured

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

  1. Disease-free survival as measured by the Kaplan-Meier method at 3 years

Secondary outcomes (3)

  1. Disease-free survival as measured by the Kaplan-Meier method at 2 years

  2. Duration of response (complete or partial response)

  3. Overall disease-free survival

Timeline

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

  1. First posted11 May 2006 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00324831
Sponsor's protocol ID
CDR0000466677
Other IDs
FAV-ID-11, FAV-WIRB-20051774
Status last verified
Mar 2007
First submitted
10 May 2006
Last updated
18 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Favrille at 2 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: paused, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Disease-free survival as measured by the Kaplan-Meier method at 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 NCT00324831.

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 18 Dec 2013.

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