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RATIONALE: Sometimes neuroblastoma will regress without treatment, but sometimes additional treatment may be necessary. Giving more than one chemotherapy drug after surgery to remove the tumor may kill more tumor cells.
PURPOSE: Phase II trial to study combination chemotherapy or observation following surgery in treating infants with neuroblastoma.
OBJECTIVES: I. Determine the incidence of spontaneous regression of localized neuroblastoma in infants. II. Determine how many infants with neuroblastoma do not need chemotherapy. III. Evaluate the time course of regression by radiologic criteria and catecholamine metabolites. IV. Determine the reliability of risk estimation by molecular characteristics (N-myc amplification, CD44, del 1p) compared to clinical criteria. V. Evaluate whether reduced therapeutic toxicity results in a decrease in treatment-related deaths. VI. Correlate cytostatic drug levels with chemotherapy side effects.
OUTLINE: All patients undergo resection of the primary tumor and N-myc determination within 6 months of age, unless critically ill, then are treated according to risk. Patients with amplified N-myc or with indeterminate N-myc amplification but with other risk features are treated per protocol GER-NB90. Stage 4S patients who are critically ill or thrombocytopenic receive doxorubicin, vincristine, and cyclophosphamide over 7 days. Patients with no amplification of N-myc are observed for 6 months (until between 12 and 18 months of age). Patients with minimal residual disease (less than 10% or diameter no greater than 2-5 mm) continue observation, while those with residual disease but no disease progression undergo repeat biopsy. Patients whose biopsy indicates tumor regression also continue observation. All other patients, including those with disease progression, are treated per protocol GER-NB90.
PROJECTED ACCRUAL: 36-44 patients per year will be accrued (22-27 patients with stages 1-3, 8-10 patients with stage 4S, and 6-7 patients with stage 4 neuroblastoma).
Primary Purpose: Treatment
cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, conventional surgery
University of Cologne
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:36:09-0400
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma. PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuro...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so tha...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may sh...
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 topotecan and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with...
Clinical use of doxorubicin, an effective chemotherapeutic agent, has limited uses due to dose-dependent cardiac toxicity. It has been supposed that the production of free radicals and calcium ions ov...
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...
Dose-dense administration of chemotherapy and the addition of taxanes to anthracycline-based adjuvant chemotherapy have improved breast cancer survival substantially. However, clinical trials directly...
This study aimed to elucidate the benefits of nanoformulation of doxorubicin (DOX) and thymoquinone (TQ) loaded with nanofibers of poly-N-acetyl glucosamine (pGlcNAc), which is known as F2 gel, over t...
To evaluate the effect of Penehyclidine Hydrochloride Injection on pulmonary ischemia-reperfusion in aortic dissection surgery.This study was a prospective randomized controlled trial. Between Septemb...
Derivatives of chondroitin which have a sulfate moiety esterified to the galactosamine moiety of chondroitin. Chondroitin sulfate A, or chondroitin 4-sulfate, and chondroitin sulfate C, or chondroitin 6-sulfate, have the sulfate esterified in the 4- and 6-positions, respectively. Chondroitin sulfate B (beta heparin; DERMATAN SULFATE) is a misnomer and this compound is not a true chondroitin sulfate.
An enzyme that catalyzes the activation of sulfate ions by ATP to form adenosine-5'-phosphosulfate and pyrophosphate. This reaction constitutes the first enzymatic step in sulfate utilization following the uptake of sulfate. EC 220.127.116.11.
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 arylsulfatase that catalyzes the hydrolysis of the 4-sulfate groups of the N-acetyl-D-galactosamine 4-sulfate units of chondroitin sulfate and dermatan sulfate. A deficiency of this enzyme is responsible for the inherited lysosomal disease, Maroteaux-Lamy syndrome (MUCOPOLYSACCHARIDOSIS VI). EC 18.104.22.168.
An enzyme that specifically cleaves the ester sulfate of iduronic acid. Its deficiency has been demonstrated in Hunter's syndrome, which is characterized by an excess of dermatan sulfate and heparan sulfate. EC 22.214.171.124.
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...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...