ACNS1123, Phase 2 Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors

Study ID
STU 062012-095

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
Natasha Anderson
214-456-6439
natasha.anderson@childrens.com

Principal Investigator
Naomi Winick

Summary

Stratum 1: 6 cycles of induction chemotherapy (cycle a - carboplatin/etoposide alternating with cycle B- ifosfamide/etoposide) if CR or PR is observed, then patient will receive radiation therapy: 30.6 Gy WVi + 23.4 Gy boost to primary tumor site. if progressive disease (PD) is observed with normal tumor markers, second-look surgery will be strongly recommended to assess CR/PR. if the patient shows evidence of CR or PR after the second-look surgery, they will then receive radiation therapy: 30.6 Gy WVi + 23.4 Gy boost to primary tumor site. if PD with increasing or positive markers is observed, or if the second-look surgery is not performed, the patient will be off protocol therapy. Stratum 2: 4 cycles of induction chemotherapy (cycle a - carboplatin/etopside) if CR or CCR is observed with normal tumor markers, patient will receive radiation therapy: 18Gy WVi + 12 Gy boost to primary site. Germinoma patients with PR, SD with [Greater Than] 1.5 cm residual and PD with normalization of hCG should be considered for second look surgery. if histology confirms mature teratoma or non-viable tumor, WVi to 18 Gy followed by local boost of 12 Gy to a total dose of 30 Gy will be delivered. Patients with [Greater Than] 0.5 cm (suprasellar) or [Greater Than] 1 cm (pineal) but less than or equal to 1.5 cm residual who do not undergo second-look surgery will be treated with WVi to 24 Gy followed by local boost of 12 Gy to a total dose of 36 Gy. if second-look surgery is not performed and patients do not meet criteria for at least PR with less than or equal to 1.5cm residual disease, patients will be off protocol therapy.

Participant Eligibility


* Patient must be between 3 and 21 years old

* Patient must be newly diagnosed with localized CNS NGGCT or germinoma present in the anatomic locations specified in the protocol

* Patients must have hCG[BETA] and AFP levels measured as specified in the protocol

* No evidence of disease in the lumbar cerebrospinal fluid

* Patient must also be enrolled in the ALTE07C1 study

* Adequate marrow function as specified in the protocol

* Adequate renal function as specified in the protocol

* Adequate liver function as specified in the protocol

* Adequate CNS function as specified in the protocol