(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)
Evaluation of the Safety and Efficacy of Nipent, Cytoxan, and Rituxan [Completed]
The goal of the clinical research study is to learn if treatment with a combination of three
drugs, Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin), will help
to control the disease in patients with previously untreated non-Hodgkin's lymphoma, CLL, or
bulky lymphoma. The safety of this treatment will also be studied.
Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy [Recruiting]
No prospective randomized trials have evaluated the most efficacious dose of
cyclophosphamide to mobilize autologous stem cells. We previously demonstrated that the
time to collection of autologous hematopoietic stem cells is 10-12 days following the one
dose of cyclophosphamide and daily G-CSF (granulocyte-colony stimulating factor).9 This
prospective randomized trial is designed to determine if a lower dose of cyclophosphamide
(1. 5 gm/m2) will be as efficacious as the intermediate dose (3 gm/m2), based on cell number
collected, number of apheresis required and resource utilization.
A Trial of Dasatinib (PDGFR and SRC Inhibitor), Temsirolimus and Cyclophosphamide in Patients With Advanced Solid Tumors [Not yet recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the
combination of dasatinib, cyclophosphamide, and temsirolimus that can be given to patients
with advanced solid tumors. The safety of this drug combination will be studied. As
secondary aim the study will evaluate treatment response to this combination and biological
Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients [Completed]
The goal of this clinical research study is to find the highest tolerable dose of the drugs
clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or
refractory ALL. The safety of the combination treatment will also be studied.
1. To establish toxicities and safety of the proposed combination
2. To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the
combination to proceed with the phase II part of the study
3. To establish the efficacy (complete and overall response) of the proposed combination.
4. To analyze pharmacokinetic (PK) and pharmacodynamic (PD) properties of clofarabine as
well as the impact on DNA repair of leukemic blasts with the proposed combination.
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
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