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Nipent (Pentostatin) - Summary

 
 



WARNING

NIPENT should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of higher doses than those specified (see DOSAGE AND ADMINISTRATION) is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used NIPENT at higher doses (20-50 mg/m2 in divided doses over 5 days) than recommended.

In a clinical investigation in patients with refractory chronic lymphocytic leukemia using NIPENT at the recommended dose in combination with fludarabine phosphate, 4 of 6 patients entered in the study had severe or fatal pulmonary toxicity. The use of NIPENT in combination with fludarabine phosphate is not recommended.

 

NIPENT SUMMARY

Nipent® (pentostatin for injection)

NIPENT® (pentostatin for injection) is supplied as a sterile, apyrogenic, lyophilized powder in single-dose vials for intravenous administration. Each vial contains 10 mg of pentostain and 50 mg of Mannitol, USP. The pH of the final product is maintained between 7.0 and 8.5 by addition of sodium hydroxide or hydrochloric acid.

NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.


See all Nipent indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Nipent (Pentostatin)

Prophylaxis of graft-versus-host disease in unrelated donor transplantation with pentostatin, tacrolimus, and mini-methotrexate: a phase I/II controlled, adaptively randomized study. [2011.01.20]
PURPOSE: Acute graft-versus-host disease (aGVHD) is a major cause of morbidity and mortality after matched unrelated, related, or mismatched related donor hematopoietic stem-cell transplantation (HSCT). Improved GVHD prevention methods are needed. Pentostatin, an adenosine deaminase inhibitor, leads to lymphocyte depletion with low risk of myelosuppression. We hypothesized that addition of pentostatin to GVHD prophylaxis with tacrolimus and mini-methotrexate may improve outcomes, and we conducted a Bayesian adaptively randomized, controlled, dose-finding study, taking into account toxicity and efficacy... CONCLUSION: Pentostatin increased the likelihood of success as defined here, and should be further investigated in larger randomized, confirmatory studies.

Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network. [2009.07.16]
Acute graft-versus-host disease (aGVHD) is the primary limitation of allogeneic hematopoietic cell transplantation...

Long-term follow-up of remission duration, mortality, and second malignancies in hairy cell leukemia patients treated with pentostatin. [2000.11.01]
The nucleoside analogue, pentostatin, has demonstrated high complete response rates and long relapse-free survival times in patients with hairy cell leukemia, a disease that historically had been unresponsive to treatment. Long-term data on duration of overall survival and relapse-free survival and incidence of subsequent malignancies with this agent are lacking...

Randomized comparison of pentostatin versus interferon alfa-2a in previously untreated patients with hairy cell leukemia: an intergroup study. [1995.04]
PURPOSE: Therapy of hairy cell leukemia has markedly improved. Interferon alfa-2a and pentostatin are active agents. The National Cancer Institute organized an intergroup trial to compare these agents prospectively in untreated patients... CONCLUSION: Both agents were well tolerated. Pentostatin produced higher response rates, and the responses were durable. Patient age and clinical status had an impact on outcome with pentostatin. Pentostatin is effective therapy for hairy cell leukemia.

Effect of adenosine deaminase inhibition with pentostatin on myocardial stunning in dogs. [1995.03]
Pentostatin (2-deoxycoformycin) is a potent inhibitor of adenosine deaminase and has been demonstrated to augment endogenous adenosine levels during regional and global myocardial ischemia. Based on the rationale that increasing endogenous adenosine during ischemia may be cardioprotective, the objective of this study was to determine if adenosine deaminase inhibition with pentostatin could improve postischemic contractile dysfunction (stunning) in open-chest anesthetized dogs...

more studies >>

Clinical Trials Related to Nipent (Pentostatin)

Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies [Recruiting]
The purpose of the study is to determine if participants who receive the GVHD prophylaxis medication pentostatin will have less severe hepatic toxicities than those receiving MTX. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin recipients.

Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma [Recruiting]
RATIONALE: Monoclonal antibodies, such as ofatumumab, 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. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving ofatumumab together with pentostatin and cyclophosphamide may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying how well giving ofatumumab together with pentostatin and cyclophosphamide works in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies [Completed]
The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.

Trial of Pentostatin Plus Cyclophosphamide With Ofatumumab (PCO) in Older Patients With Chronic Lymphocytic Leukemia [Recruiting]
This is a phase II multicenter, non-comparative, open label study in older previously untreated Chronic Lymphocytic Leukaemia patients, requiring therapy, aimed at defining the efficacy profile (ORR, CRR and TTP) of pentostatin and cyclophosphamide given in combination with Ofatumumab (PCO).

Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia [Recruiting]
Background:

- Researchers are attempting to develop new treatments for hairy cell leukemia (HCL) that

has not responded well to or has recurred after standard HCL therapies. One nonstandard treatment for HCL is rituximab, an antibody that binds to the cancer cells and helps the immune system destroy them. By combining rituximab with other anti-cancer drugs, researchers hope to determine whether the combined drugs are successful in treating HCL.

- Pentostatin and bendamustine are two anti-cancer drugs that have been used to treat

different kinds of blood and immune system cancers. Bendamustine is approved to treat other kinds of leukemia and lymphoma, but it has not been used to treat HCL. Pentostatin has been used for more than 20 years to treat HCL, but it has not been combined with rituximab in official clinical trials.

Objectives:

- To determine whether rituximab with either pentostatin or bendamustine is a more

effective treatment for HCL than rituximab alone.

- To determine whether pentostatin or bendamustine is a more effective treatment for HCL

when combined with rituximab.

Eligibility:

- Individuals at least 18 years of age who have been diagnosed with hairy cell leukemia that

has not responded well to or has relapsed after standard HCL therapies.

Design:

- The study will last for four treatment cycles of 28 days each.

- Prior to the study, participants will be screened with a full medical history and

physical exam, bone marrow biopsy (if one has not been performed in the last 6 months), computed tomography (CT) or ultrasound scan, tumor measurements, and other tests as required by the researchers. Participants will provide blood and urine samples at this time as well.

- Rituximab with bendamustine: Participants will receive rituximab on Days 1 and 15 of

each cycle and bendamustine on Days 1 and 2 of each cycle, for a total of four cycles.

- Rituximab with pentostatin: Participants will receive rituximab on Days 1 and 15 of

each cycle and pentostatin on rituximab on Days 1 and 15 of each cycle, for a total of four cycles.

- Participants will have regular tests during the treatment cycles, including bone marrow

biopsies and CT or ultrasound scans. Participants will also provide regular blood and urine samples to assess the results of treatment.

more trials >>

Reports of Suspected Nipent (Pentostatin) Side Effects

Fall (4)Dyspnoea (4)Ascites (4)Dehydration (4)Atelectasis (3)Confusional State (3)Nuchal Rigidity (3)Cardiomegaly (3)Pericardial Effusion (3)Fatigue (3)more >>


Page last updated: 2011-12-09

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