Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Recurrence

Lymphoma

Lymphoma, Non-Hodgkin

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Lymphosarcoma

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Rituximab

Bortezomib

Immunoglobulins

Enzyme Inhibitors

Immunoglobulins, Intravenous

Immunologic Factors

Antineoplastic Agents, Immunological

bortezomib

rituximab

antibody therapy

biological therapy

enzyme inhibitor therapy

monoclonal antibody therapy

John Densmore, MD

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving bortezomib together with rituximab may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, including Waldenstrom's macroglobulinemia.

OBJECTIVES:

Primary

* Assess the safety and tolerability of bortezomib and rituximab in patients with relapsed or refractory, B-cell non-Hodgkin's lymphoma.
* Determine the overall response rate (partial response, complete response unconfirmed, and complete response) in these patients.

Secondary

* Estimate the duration of response in patients treated with this regimen.
* Estimate the time to disease progression in patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV over 3-5 seconds once weekly in weeks 1-4 and rituximab IV over 5-6 hours once weekly in weeks 1-5\*. Treatment repeats every 5 weeks for 2 courses. Patients achieving stable disease or better receive an additional 4 courses of bortezomib alone.

NOTE: \*Patients receive rituximab in weeks 1-3 only during course 2 of treatment.

After completion of study treatment, patients are followed periodically for at least 18 months.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

VELCADE (Bortezomib) for Injection - Phase II Study of Bortezomib and Rituximab in Relapsed or Refractory Non-Hodgkin's Lymphoma

National Cancer Institute (NCI)

University of Virginia

Neoplasm Metastasis

Cyclophosphamide

Muromonab-CD3

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

muromonab-CD3

cyclophosphamide

Charles L. Wiseman, MD, FACP

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody and cyclophosphamide in treating patients with metastatic cancer.

OBJECTIVES: I. Evaluate the clinical feasibility and toxicity of monoclonal antibody OKT3 given with low-dose cyclophosphamide in patients with advanced malignancies. II. Perform serial immune monitoring on patients treated with this regimen. III. Identify any clinical responses produced by this regimen.

OUTLINE: Biological Response Modifier Therapy with Suppressor Cell Inhibition. Anti-CD3 Murine Monoclonal Antibody OKT3, MOAB OKT3; with Cyclophosphamide, CTX, NSC-26271.

PROJECTED ACCRUAL: At least 9 evaluable patients per diagnostic category will be required initially; if any response is seen during the dose-finding portion of the study, a total of 24 patients with that diagnosis will be entered.

Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer

A PHASE I-II TRIAL OF MUROMONAB (OKT-3) WITH LOW-DOSE CYCLOPHOSPHAMIDE

St. Vincent Medical Center - Los Angeles

Leukemia

Immunotoxins

Immunotoxin HA22

Immunoconjugates

Immunotoxin therapy

CAT-8015 Immunotoxin

Biological therapy

Antibody Therapy

Monoclonal Antibody Therapy

Marie Fuerst, RN, MS

Peter Rosen, MD

NCI Clinical Trials Referral Office

Robert J Kreitman, MD

Krzysztof Jamroziak, MD

Tadeusz Robak, Professor

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not responded to chemotherapy, surgery or radiation therapy.

PURPOSE: Phase 1 dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have Non-Hodgkin's lymphoma and do not respond to treatment.

Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease

A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)

Cambridge Antibody Technology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Bevacizumab

Irinotecan

Angiogenesis Inhibitors

Growth Inhibitors

Topoisomerase I Inhibitors

Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.

Franco Muggia, MD

The purpose of the study is to evaluate the efficacy and toxicity of irinotecan in the treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when combined with bevacizumab.

Accumulating data suggests that angiogenesis plays a critical role in the formation and development of a number of solid tumors including ovarian cancer. For women with ovarian cancer, a direct relationship between vascular endothelial growth factor (VEGF) expression and tumor vascularity has been documented. In vivo and in vitro data has demonstrated that increased angiogenesis and microvessel density are negative prognostic factors for women with ovarian cancer. These observations have fueled interest in incorporating anti-angiogenic agents into ovarian cancer treatment regimens.

Several phase II trials of irinotecan in patients with epithelial ovarian cancer showed that the drug had efficacy in both chemotherapy-naïve patients and in those who had been previously treated with standard therapies, including platinum-based compounds, radiation, or both. Combination of bevacizumab, an antibody against VEGF, and irinotecan was studied in colorectal cancer and malignant brain neoplasms. In these trials, the combination was shown to be safe and effective.

The purpose of this study is to evaluate the efficacy and toxicity of irinotecan in the treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when combined with bevacizumab. In this phase II open-label study patients will be treated with bevacizumab 15 mg/kg and irinotecan 175mg/m\^2 every 3 weeks. Patients will undergo pre-treatment evaluation within 4 weeks of enrolling into the study. Clinical and laboratory evaluation will be performed every 3 weeks. Imaging studies and CA-125 measurements will be used to assess response to treatment.

Irinotecan and Bevacizumab for Recurrent Ovarian Cancer

Phase II Study of Irinotecan in Combination With Bevacizumab for the Treatment of Recurrent Ovarian Cancer.

The PFS rate at 6 months is the percentage of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is evaluated by Response and Evaluation Criteria in Solid Tumor (RECIST) 1.0 or CA125 criteria if no measurable disease as doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level.

ORR is defined as the percentage of all patients with confirmed partial response (PR) or complete response (CR). PR and CR are evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by \> 50%; CR: CA125 decreases to the normal range).

Defined as the length of time from the start of treatment that half of the patients are still alive and without disease progression. Progression is evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by \> 50%; CR: CA125 decreases to the normal range; progression is defined on the basis of a confirmed doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level)

Defined as the length of time from the start of treatment that half of the patients are still alive.

Genentech, Inc.

NYU Langone Health

All AEs regardless of attribution are reported.

Irinotecan With Bevacizumab

Irinotecan is administered every 3 weeks at a dose of 175 mg/m\^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.

Irinotecan

Bevacizumab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Number of prior regimens

Progression Free Survival (PFS) Rate at 6 Months

Overall Response Rate (ORR)

Median Progression Free Survival

Median Overall Survival

Diarrhea

Fatigue

Pain

Hypertension

Nausea

Proteinuria

Vomiting

Febrile neutropenia

GI obstruction: colon

GI perforation

Leukopenia

Any patients who had at least one dose of treatment

Number of Patients Who Experienced Grade 3 and Higher Toxicities

Overall Study

Digestive System Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Pancreatic Cancer

Gastrointestinal Agents

Gemcitabine

Mitogens

Pancrelipase

Pancreatin

Antimetabolites

bevacizumab

gemcitabine hydrochloride

adjuvant therapy

anti-cytokine therapy

antiangiogenesis therapy

chemotherapy

conventional surgery

growth factor antagonist therapy

surgery

Richard E. Royal, MD, FACS

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.

OBJECTIVES:

Primary

* Compare the disease-free interval in patients with adenocarcinoma of the pancreas treated with surgical resection followed by adjuvant gemcitabine hydrochloride with vs without bevacizumab.

Secondary

* Compare overall survival in patients treated with these regimens.
* Evaluate tumor gene expression profiles and levels of tumor angiogenesis markers to establish prognostic indicators for response in patients treated with these regimens.

OUTLINE: This is a randomized, controlled study.

All patients undergo surgical resection for the pancreatic tumor. Within 4-8 weeks after surgery, patients are stratified according to projected 2-year survival (≤ 5% vs \> 5% and ≤ 33% vs \> 33%). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses. Patients then receive bevacizumab IV alone every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.

Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer

Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma	NCT00265928	Lymphoma	bortezomib rituximab antibody therap... biological ther... enzyme inhibito... monoclonal anti...	18 Years -	National Cancer Institute (NCI)
Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer	NCT00002482	Unspecified Adu...	antibody therap... biological ther... muromonab-CD3 cyclophosphamid...	18 Years -	National Cancer Institute (NCI)
Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease	NCT00515892	Leukemia Non-Hodgkin's L... NHL	Immunotoxin the... CAT-8015 Immuno... Biological ther... Antibody Therap... Monoclonal Anti...	18 Years -	Cambridge Antibody Technology
Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease	NCT00515892	Leukemia Non-Hodgkin's L... NHL	Immunotoxin the... CAT-8015 Immuno... Biological ther... Antibody Therap... Monoclonal Anti...	18 Years -	Cambridge Antibody Technology
Irinotecan and Bevacizumab for Recurrent Ovarian Cancer	NCT01091259	Ovarian Cancer Fallopian Tube ... Primary Periton...	Irinotecan Bevacizumab	18 Years -	NYU Langone Health
Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer	NCT00253526	Adenocarcinoma ... Recurrent Pancr... Stage I Pancrea... Stage II Pancre... Stage III Pancr...	bevacizumab gemcitabine hyd... adjuvant therap... anti-cytokine t... antiangiogenesi... antibody therap... biological ther... chemotherapy conventional su... growth factor a... monoclonal anti... surgery	18 Years -	National Cancer Institute (NCI)

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