(cyclophosphamide for injection, USP)
(cyclophosphamide tablets, USP)
CYTOXAN® (cyclophosphamide for injection, USP) is a sterile white powder containing cyclophosphamide monohydrate. CYTOXAN Tablets (cyclophosphamide tablets, USP) are for oral use and contain 25 mg or 50 mg cyclophosphamide (anhydrous). Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards.
CYTOXAN is indicated for the following:
CYTOXAN, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. The following malignancies are often susceptible to CYTOXAN treatment:
Biopsy Proven “Minimal Change” Nephrotic Syndrome in Children
- Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma.
- Multiple myeloma.
- Leukemias: Chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia in children (CYTOXAN given during remission is effective in prolonging its duration).
- Mycosis fungoides (advanced disease).
- Neuroblastoma (disseminated disease).
- Adenocarcinoma of the ovary.
- Carcinoma of the breast.
CYTOXAN is useful in carefully selected cases of biopsy proven “minimal change” nephrotic syndrome in children but should not be used as primary therapy. In children whose disease fails to respond adequately to appropriate adrenocorticosteroid therapy or in whom the adrenocorticosteroid therapy produces or threatens to produce intolerable side effects, CYTOXAN may induce a remission. CYTOXAN is not indicated for the nephrotic syndrome in adults or for any other renal disease.
Published Studies Related to Cytoxan (Cyclophosphamide)
Comparison of high and low dose of cyclophosphamide in lupus nephritis patients: a long-term randomized controlled trial. [2011.09]
To evaluate the outcome of low doses of cyclophosphamide (Cyclo) therapy in lupus nephritis (LN) patients, we studied 117 biopsy-proven, de novo LN WHO class IV patients double-blinded and randomized in December 1997 to receive Cyclo in different doses; Group I (n=73) received Cyclo 10 mg/kg monthly for six months then every two months for 12 months...
Autologous non-myeloablative haemopoietic stem-cell transplantation compared with pulse cyclophosphamide once per month for systemic sclerosis (ASSIST): an open-label, randomised phase 2 trial. [2011.08.06]
BACKGROUND: Non-randomised studies of haemopoietic stem-cell transplantation (HSCT) in systemic sclerosis have shown improvements in lung function and skin flexibility but high treatment-related mortality. We aimed to assess safety and efficacy of autologous non-myeloablative HSCT in a phase 2 trial compared with the standard of care, cyclophosphamide... INTERPRETATION: Non-myeloablative autologous HSCT improves skin and pulmonary function in patients with systemic sclerosis for up to 2 years and is preferable to the current standard of care, but longer follow-up is needed. FUNDING: None. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation. [2011.08.04]
As part of the randomized MRC Myeloma IX trial, we compared an attenuated regimen of cyclophosphamide, thalidomide, and dexamethasone (CTDa; n = 426) with melphalan and prednisolone (MP; n = 423) in patients with newly diagnosed multiple myeloma ineligible for autologous stem-cell transplantation...
Randomized multicenter trial of the effects of melanoma-associated helper peptides and cyclophosphamide on the immunogenicity of a multipeptide melanoma vaccine. [2011.07.20]
PURPOSE: This multicenter randomized trial was designed to test whether melanoma-associated helper peptides augment CD8(+) T-cell responses to a melanoma vaccine and whether cyclophosphamide (CY) pretreatment augments CD4(+) or CD8(+) T-cell responses to that vaccine... CONCLUSION: Melanoma-associated helper peptides paradoxically decreased CD8(+) T-cell responses to a melanoma vaccine (P < .001), and CY pretreatment had no immunologic or clinical effect. Prior work showed immunologic and clinical activity of 6MHP alone. Possible explanations for negative effects on CD8 responses include modulation of homing receptor expression or induction of antigen-specific regulatory T cells.
Prospective randomized trial of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus paclitaxel and FAC (TFAC) in patients with operable breast cancer: impact of taxane chemotherapy on locoregional control. [2011.07]
A previous randomized trial (CALGB 9344/Intergroup 0148) compared four cycles of adjuvant doxorubicin/cyclophosphamide (AC) to four cycles of AC plus four cycles of paclitaxel (AC + T) and demonstrated that the addition of paclitaxel improved locoregional control (LRC) in patients with node-positive breast cancer...
Clinical Trials Related to Cytoxan (Cyclophosphamide)
Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394) [Active, not recruiting]
To compare disease-free survival (DFS), overall survival (s), and toxicity of high-isk
primary breast cancer patients with negative axillary lymph nodes or with one to three
positive nodes treated with adjuvant high-dose chemotherapy with doxorubicin plus
cyclophosphamide (AC), versus high-dose sequential chemotherapy with doxorubicin followed by
High-Dose Intravenous (IV) Cyclophosphamide Versus Monthly IV Cyclophosphamide [Active, not recruiting]
This study compares the effectiveness of high-dose cyclophosphamide treatment with the "gold
standard" treatment, monthly intravenous (IV) cyclophosphamide, in people with moderate to
severe lupus that does not respond to high-dose corticosteroid therapy. We will give patients
either IV cyclophosphamide (750 milligrams per square meter of body surface area) monthly for
6 months, followed by quarterly maintenance therapy, or high-dose IV cyclophosphamide (50
milligrams per kilogram body weight per day) for the first four days of the study. Patients
will be followed for 24 months after therapy.
Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT) [Recruiting]
Study Phase: phase 1 and phase 2
Objective: Evaluation of the effect of lenalidomide, cyclophophamide and prednisone (REP) in
patients with relapsed multiple myeloma previously treated with lenalidomide
Study design: prospective, multicenter, non-randomized
Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer [Active, not recruiting]
The purpose of this study is to find out what effects (good and bad) a combination of
cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.
Efficacy Study of Sorafenib and Cyclophosphamide to Treat Neuroendocrine Tumors [Recruiting]
This is a phase II clinical trial to assess the efficacy of the combination of metronomic
cyclophosphamide and tailored sorafenib dosing in advanced, progressive NET. NET are highly
vascular tumors, and high VEGF expression has been correlated with worse clinical and
pathological characteristics as well as poor prognosis. A novel antiangiogenic approach
relies on targeting not only the endothelial cells but also rendering them more sensitive to
VEGFR blockade by achieving pericyte detachment. In this study, the dose of sorafenib will
be titrated up to a maximum of 800mg BID based on patients' toxicity and on a novel
pharmacodynamic assay that measures inhibition of molecular target(PDGFR) in patients'
peripheral blood mononuclear cells. Dual VEGFR targeting is achieved by administering
sorafenib plus metronomic low dose cyclophosphamide.
Reports of Suspected Cytoxan (Cyclophosphamide) Side Effects
Neuropathy Peripheral (11),
Febrile Neutropenia (11),
Respiratory Disorder (9),
OFF Label USE (7),
Dyspnoea (7), more >>
Page last updated: 2011-12-09