Track topics on Twitter Track topics that are important to you
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known which combination chemotherapy regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, is more effective in treating newly diagnosed neuroblastoma.
PURPOSE: This phase III trial is studying combination chemotherapy to see which regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, works in treating infants with newly diagnosed neuroblastoma.
- Determine the outcome, in terms of survival and morbidity, in infants with localized, unresectable, non-MYCN-amplified neuroblastoma treated with reduced-intensity chemotherapy.
- Determine the survival of infants with stage 4S neuroblastoma, no MYCN amplification, and no bone, CNS, or pleural/lung metastases treated with short-course intensive chemotherapy.
- Determine the survival of infants with stage 4S neuroblastoma, no MYCN amplification, and bone, CNS, or pleural/lung metastases not treated with intensive high-dose chemotherapy consolidation.
- Determine the survival of infants with any stage (except stage 1) neuroblastoma and MYCN amplification treated with intensive consolidation high-dose chemotherapy followed by autologous bone marrow or stem cell support.
- Correlate outcome with factors other than stage and MYCN status in infants with neuroblastoma.
- Define the behavior of neuroblastoma in infants treated with these regimens.
- Determine prognostic criteria in infants treated with these regimens.
- Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in infants who do not have other adverse features, such as MYCN amplification.
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 4 treatment regimens according to disease criteria. Patients who are not eligible for any of these regimens (stage 1 or resectable stage 2 disease) undergo surgical resection followed by observation.
- Regimen NB 99.1 (unresectable stage 2 or 3): Patients are treated according to spinal cord involvement and presence of neurological symptoms.
- Group I (no evidence of spinal cord involvement):
- CO therapy: Patients receive cyclophosphamide IV on days 1-5 and vincristine IV on day 1. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression. Resectability is assessed after every 2 courses of chemotherapy; if tumor is resectable, then patients undergo surgery followed by observation only. If, after 4 courses of CO, the tumor is still not resectable or disease has progressed, then patients proceed to VP-CARBO therapy.
- VP-CARBO therapy: Patients receive carboplatin IV over 1 hour and etoposide phosphate IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses. If the tumor is then deemed resectable, the patient undergoes surgery. If the tumor is not resectable or disease has progressed, then patients proceed to CADO therapy.
- CADO therapy: Patients receive cyclophosphamide IV over 1 hour on days 1-5, doxorubicin hydrochloride IV over 6 hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days for 2 courses. Patients then proceed to resection or biopsy.
- Group II (dumbbell tumors, spinal cord compression symptoms or life-threatening symptoms [e.g., respiratory obstruction]): Patients receive 2 courses of VP-CARBO therapy. Patients who achieve a response proceed to surgery or biopsy if the extraspinal portion is resectable. Patients with nonresponding disease or an unresectable extraspinal portion of the tumor receive 2 courses of CADO therapy and then undergo surgery or biopsy. Patients with dumbbell tumors but no spinal cord compression symptoms are treated as in group I.
- Regimen NB 99.2 (stage 4S or stage 4 without bone, pleura/lung, or CNS metastases and no MYCN amplification): Patients who do not have severe or life-threatening symptoms are observed for spontaneous regression of disease. Patients with severe symptoms receive 1 course of VP-CARBO therapy. Patients with a Philadelphia score ≥ 2 (or ≥ 1 for neonates [< 1 month old]) receive a second course of VP-CARBO therapy. If disease does not respond to 2 courses of VP-CARBO therapy, patients receive up to 4 courses of CADO therapy. Treatment ceases after response is obtained. Surgery is allowed but not required.
- Regimen NB 99.3 (skeletal bone, pleural, and/or CNS metastases, no MYCN amplification): Patients receive 2 courses of VP-CARBO therapy. Patients with responding disease receive 2 more courses and then proceed to surgery (if possible). Patients with disease progression or no response after the first 2 courses of VP-CARBO therapy and patients who do not experience metastatic complete response (CR) after 4 courses of VP-CARBO therapy receive up to 4 courses of CADO therapy. Patients proceed to surgery, if possible, after 2-4 courses of CADO therapy.
- Regimen NB 99.4 (stages 2-4 disease with MYCN amplification): Patients receive 2 courses of VP-CARBO therapy followed by 2 courses of CADO therapy and then surgery (if not already performed). Patients receive filgrastim (G-CSF) subcutaneously for 5 days between the second course of CADO therapy and surgery. Patients also undergo collection of their bone marrow or peripheral blood stem cells (PBSC). Patients who undergo surgery receive 1 course of VP-CARBO therapy followed by 1 course of CADO therapy postsurgery. At least 3 weeks after the third course of CADO therapy, patients receive high-dose chemotherapy comprising busulfan every 6 hours on days -7 to -3 and melphalan IV on day -2 followed by autologous bone marrow or PBSC infusion on day 0. At least 2 months later, patients undergo radiotherapy to the primary tumor site, even if complete surgical resection has been accomplished. Patients with stage 4 disease who do not achieve metastatic CR after chemotherapy (before surgery) go off study.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
filgrastim, busulfan, carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide phosphate, melphalan, vincristine sulfate, autologous bone marrow transplantation, bone marrow ablation with stem cell support, conventional surgery, peripheral bloo
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:23:06-0400
This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-neg...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim or filgrastim-SD/01 ma...
RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by ...
RATIONALE: Drugs used in chemotherapy, such as etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone, use different ways to stop cancer cells from dividing so they stop gro...
This phase II trial studies how well etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride with asparaginase work in treating patients with acute lymp...
We studied rates of granulocyte and platelets recovery in 359 consecutive subjects receiving blood cell infusions in the context of autotransplants for plasma cell myeloma (N = 216) and lymphomas ...
Carboplatin plus etoposide (CE) is a standard treatment for elderly patients with extensive-disease small cell lung cancer (ED-SCLC). However, amrubicin monotherapy (AMR) may be a feasible alternative...
Medulloblastoma is the most common malignant brain tumor among children. Although molecular study has been included in the new classification, in developing countries with limited resources the previo...
High-dose chemotherapy and autologous stem cell transplantation (ASCT) is the current standard of care for relapsed non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Conditioning regimens with hig...
To compare the pharmacokinetic bioequivalence and safety of a generic pegylated liposomal doxorubicin formulation (SPIL DXR hydrochloride liposome injection) with that of the reference products, Caely...
A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.
A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.
An alkylating agent having a selective immunosuppressive effect on BONE MARROW. It has been used in the palliative treatment of chronic myeloid leukemia (MYELOID LEUKEMIA, CHRONIC), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
An organoplatinum compound that possesses antineoplastic activity.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...