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Lymphoma
Trials
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| TITLE |
LPI 1404: A Phase II Multicenter Study of ONTAK (Denileukin Diftitoxin) in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma |
| DESCRIPTION |
This research study is being done to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin’s lymphoma (NHL) in patients whose disease has not responded to prior treatments or has relapsed after an initial response to prior treatments. Patients will be treated with ONTAK for 3 days in a row during the first week, then one-time per week for at least 8 weeks, then depending upon the patient’s response, 8 additional times (once per week). After 16 weeks of treatment, additional monthly doses may be given. |
| ELIGIBILITY |
- Relapsed/refractory B-cell NHL
- Histological documentation of diffuse large B-cell lymphoma, follicular lymphoma (grade 1, 2 or 3), small lymphocytic lymphoma, or transformed B-cell lymphoma
- Measurable disease, with at least one lymph node or tumor mass measuring 4 cm2
- ECOG performance status 0-2
- Failure to respond or progression of disease after 2 prior treatment regimens
- Adequate bone marrow, liver, and kidney organ function
|
| CONTACT |
Nancy Horvath, RN 216-844-7087 |
| TITLE |
E 4402 Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Patients with Low Tumor Burden Indolent Non-Hodgkin's Lymphoma |
| DESCRIPTION |
This study is being done to determine whether a singe dose of the drug rituximab given at 12 week intervals can prolong disease free control compared to giving rituximab once a week for 4 consecutive weeks at the time of disease progression. Patients will receive an initial dose of rituximab once a week for 4 weeks. After this time patients will be randomized into one of 2 groups. The first group will receive rituximab once a week for 4 weeks. The second group of patients will receive one dose of rituximab every 12 weeks. |
| ELIGIBILITY
|
- Patients must have a confirmed diagnosis of non-Hodgkin’s lymphoma.
- Patients must meet study for tumor size and staging of the disease.
- Patients must have adequate organ function and no active uncontrolled infections.
- Patients must have no prior history of cancer with a few exceptions.
- Patients may not have had prior chemotherapy, radiotherapy or immunotherapy for lymphoma with the exception of prednisone or other corticosteroids for non-lymphomatous conditions.
|
| CONTACT |
Nancy Horvath, RN 216-844-7087 |
| TITLE |
CASE 2404 Prognostic Significance of Early Positron Emission Tomography (PET) with Fluorine-18 Fluorodeoxyglucose ([18F] FDG) in Intermediate and High Grade Non-Hodgkin's Lymphoma |
| DESCRIPTION |
This study is being done to determine if the response to early PET scan can be used to predict response and the duration of response to chemotherapy for Non-Hodgkin’s lymphoma. Patients will undergo a PET scan before and after a course of chemotherapy with
cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab
(CHOP+R). Between days 7 and 10 patients will undergo a PET scan to determine response to treatment. Additional PET scans may be scheduled during the course of the study and at the completion of treatment. |
| ELIGIBILITY
|
- Patients must have a confirmed diagnosis of aggressive and intermediate grade of Non-Hodgkin’s lymphoma.
- Patients must have radiologically measurable disease by PET scan.
- Patients must have adequate staging of the lymphoma.
- Patients may not have undergone previous chemotherapy including rituximab and steroids, or radiation therapy.
- Patients must have normal liver and bone marrow function.
- Patients must have adequate cardiac function.
|
| CONTACT |
Nancy Horvath,
RN 216-844-7087 |
| TITLE |
FVID 2404: Phase II Trial of FavId (Patient-Specific
Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FAVID on Study FVID 1404 |
| DESCRIPTION |
This study will provide FavId to subjects who did not receive FavId during their participation on study FavId-06
(FVID 1404). Following the demonstration of progressive disease on FavI-06, subjects will receive salvage therapy out side of this clinical study as judged appropriate by their treating physician. Patients will receive FavId as a subcutaneous injection monthly for six months, then every 2 months for 6 months, then every 3 months starting on month 21 until disease progression. |
| ELIGIBILITY
|
- Patients must have prior enrollment in, and documented progression while entered on study FavId-06.
- Patients who received salvage therapy after completion of study FavId-06, at last 4 weeks and not longer than 4 months, between the completion of salvage treatment and the first dose of FavId on this study.
- Patents who have not received salvage therapy after completion of study FavId 06, at least 4 weeks, and not longer than 4 months, between completion of enrollment on study FavId-06 and the first dose of FavId on this study.
- Patients may not have previously received FavId on study FavId-06.
|
| CONTACT |
Nancy Horvath,
RN 216-844-7087 |
| TITLE |
FVID 1404: Phase III, Randomized, Double Blind Placebo-Controlled Trial of FavID and GM-CSF versus Placebo and GM-CSF Following Rituximab in Subjects with Follicular B-Cell Non-Hodgkin’s Lymphoma |
| DESCRIPTION |
This study will compare the time to progression in subjects receiving FavId and GM-CSF to the time to progression of patients receiving placebo/GM-CSF. All patients will receive Rituximab weekly for 4 weeks and those with either stable disease, partial response or complete response will be randomized to receive either FavId/GM-CSF or placebo/GM-CSF each month for 6 months. Patients who do not progress may continue to receive blinded injections every two months for one year then every three months until progression. |
| ELIGIBILITY |
- Patients must have histologically confirmed follicular B-cell lymphoma.
- Patients must be candidates for Rituximab as defined by being either treatment naïve, relapsed or refractory following chemotherapy, or relapsed following a prior documented response of at least 6 months duration.
- Patients may not have received more than 2 prior treatment regimens for NHL.
- Patients may not have received treatment with fludarabine within 9 months of study entry or receipt of greater than 6 cycles of fludarabine in subject’s lifetime.
- Patients must have normal bone marrow function.
|
| CONTACT |
Nancy Horvath,
RN 216-844-7087 |
| TITLE |
MSKCC 1Y02: A Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders |
| DESCRIPTION |
This study will determine the frequency and duration of complete and partial response rates for patients with low grade lymphoproliferative disorders treated with PS-341 when administered twice weekly followed by a one week rest period. Patients will receive intravenous PS-341 twice weekly for two weeks every three weeks with a one week rest period (i.e., one cycle equals three weeks). Treatment may continue for as long as there is clinical benefit or until disease progression or unacceptable toxicities. |
| ELIGIBILITY |
- Patients must have histologically or histologically confirmed using the REAL Classification, relapsed /or refractory: chronic lymphocytic leukemia; B-cell small lymphocytic lymphoma; any marginal zone lymphoma; follicle center cell lymphoma, grade I, II, III; mantle cell lymphoma; Waldenstrom’s
macroglobulinemia.
- For NHL, all patients must have measurable disease.
- Patients should have received no more than three prior regimens of conventional cytotoxic chemotherapy for at least four weeks prior to study enrollment (6 weeks for BCNU or mitomycin C). At least 7 days must have elapsed since steroids. A period of at least 3 months must have elapsed since the last administration of any monoclonal antibody.
- Patients must be at least 18 years of age.
- Patients must have adequate bone marrow, cardiac, kidney, and liver function.
|
| CONTACT |
Nancy Horvath,
RN 216-844-7087 |
|
|
| TITLE |
ICC
2402: A
Phase II Study of Bryostatin
1 and Vincristine in Patients with Low or Intermediate
Grade Non-Hodgkin’s Lymphoma Progressing or Relapsing After
a Prior Autologous Bone Marrow or Stem Cell Transplant
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| DESCRIPTION |
This trial will
evaluate response rate when bryostatin 1 is given in combination
with vincristine in patients with low and intermediate grade
non-Hodgkin’s lymphoma who have progressed or relapsed
following an autologous bone marrow or stem cell transplant.
Patients will receive Bryostatin-1 in a single 24-hour
intravenous infusion on Day 1.
This will be followed by a bolus IV injection of
vincristine. Patients
will receive Bryostatin and vincristine every 2 weeks, for a
minimum of one (1) cycle, for up to 6 months. A cycle of
therapy will be considered 4 weeks (two bryostatin infusions,
two vincristine infusions). For patients with responding or
stable disease, or freedom from progression at 6 months,
treatment may continue but bryostatin 1 and vincristine will
be given every 3 weeks and a cycle of therapy will be
considered 6 weeks.
|
| ELIGIBILITY
|
- Patients must have
received a prior autologous bone marrow or peripheral
blood stem cell rescue to be eligible for this trial
(there is no specified time interval from transplant prior
to enrollment on study. At least 4 weeks must have elapsed
since prior large-field radiation therapy. Patients must
have been off previous anti-cancer therapy for at least 4
weeks and recovered from all treatment related toxicity.
Prior vincristine therapy is allowed.
-
Patients
must have normal organ and marrow function.
-
Patients
who have had a prior allogeneic transplant are not
eligible.
-
Patients
with known brain metastases or leptomeningeal involvement
are excluded from this clinical trial.
|
| CONTACT |
Nancy
Horvath,
RN 216-844-7087 |
|
|
| TITLE |
ICC
3402: A Phase I Trial of PS-341 and Fludarabine
for Relapsed and Refractory Indolent Non-Hodgkin’s Lymphoma
and Chronic Lymphocytic Leukemia
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| DESCRIPTION |
This study will
determine the toxicity and safety of PS-341 and Fludarabine in
relapsed and refractory indolent non-Hodgkin’s lymphoma and
chronic lymphocytic leukemia.
Patients will receive PS-341, IV on days 1, 4, 8 and 11
followed by a 10 day rest.
Fludarabine will be given one hour after PS-341, IV
over 30 minutes on days 2 through 3 of each cycle (1 cycle = 3
weeks). Patients
may receive up to a maximum of 8 cycles.
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| ELIGIBILITY
|
-
Patients
must have relapsed or refractory (progressive) indolent
non-Hodgkin’s lymphoma.
-
Patients
with non-Hodgkin’s lymphoma must have measurable
disease.
-
Patients
with relapsed indolent NHL (including CLL) will be
enrolled in first, second, third relapse, or indolent NHL
patients with progressive disease.
-
Prior
fludarabine therapy is allowed; however patients should
not have been previously treated with PS-341.
-
Patients
who are candidates for potentially curative transplant
therapies should not be entered on this study.
-
Patients
must have normal bone marrow, hepatic and renal function.
|
| CONTACT |
Nancy
Horvath,
RN 216-844-7087 |
|
|
| TITLE |
E2499:
Randomized Phase III Trial of Rituximab and Autologous Stem
Cell Transplantation for B-Cell Diffuse Large Cell
LymphomaE2499 Randomized Phase III Trial of Rituximab and
Autologous Stem Cell Transplantation for B-Cell Diffuse Large
Cell Lymphoma
|
| DESCRIPTION |
This
study will compare disease-free survival in patients with
diffuse large cell lymphoma who have relapsed after achieving
complete response or have failed to achieve initial complete
response undergoing stem cell transplant with or without
Rituximab.
Patients will be stratified to one of 2 treatment arms.
Patients in Arm A will receive Rituximab prior to stem
cell removal and post stem cell reinfusion.
Patients in Arm B will not receive Rituximab.
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| ELIGIBILITY
|
-
Patients must not be newly
diagnosed.
-
Patients
may have received a maximum of 3 prior regimens (using
chemotherapy, radiation therapy, and immunotherapy).
-
Patients
must not have had any prior Rituximab antibody therapy
within the last 3 months.
-
Patients
may not have received radioimmunotherapy.
-
Patients
must have adequate bone marrow, hepatic and renal
function.
-
Patients
must have adequate cardiac and pulmonary function.
|
| CONTACT |
Thelma
Vawters 216-844-8146 |
| |