MT2004-30: Tomotherapy for Solid Tumors

Summary

RATIONALE: A peripheral blood stem cell transplant or bone marrow transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy and image-guided intensity-modulated radiation therapy used to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bone marrow radiation therapy followed by an autologous stem cell transplant in treating patients with high-risk or relapsed solid tumors.

Conditions

• Brain and Central Nervous System Tumors
• Kidney Cancer
• Liver Cancer
• Retinoblastoma
• Sarcoma

Interventions

BIOLOGICAL

filgrastim

Beginning 24 hours after chemotherapy end: 10 microgram/kg/day subcutaneously (SQ) or intravenously (IV) until absolute neutrophile count (ANC) \> 1,000/mm\^2. Starting that day, increase dose to 15 microgram/kg/day SQ or IV given as a single injection for 3 doses.

DRUG

busulfan

Part of pre-transplant conditioning chemotherapy: Administered as Busulfan 9.6 mg/kg IV (\>4 yrs of age) or 13.2 mg/kg IV (\< 4 years of age),every 6 hours on Days -8 through -6.

DRUG

etoposide

Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 100 mg/m\^2/day intravenous (IV) over 1 hour for 5 days.

DRUG

ifosfamide

Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 1.8 g/m\^2/day intravenous (IV) over 1 hour on for 5 days.

DRUG

melphalan

Part of pre-transplant conditioning chemotherapy: Administered as 100 mg/m\^2 intravenous (IV) over 30 min on Days -5 through -4.

DRUG

thiotepa

Part of pre-transplant conditioning chemotherapy: Administered as 500 mg/m\^2 intravenously (IV) over 2 hrs on Days -3 through -2.

PROCEDURE

stem cell transplantation

Regardless of whether the patient will be receiving peripheral cells or bone marrow, infusion will be intravenous on day 0, immediately after thawing.

RADIATION

tomotherapy

We plan to deliver the total marrow irradiation (TMI) to the upper half of the body using Tomotherapy TMI as explained in this protocol. However the lower part of the body will be treated with Anterior/Posterior linac based radiation treatment. Tomotherapy will then be delivered at a dose rate so as to keep the total treatment time to no more than 30 minutes. We anticipate that the dose rate will be around 400 cGy /minute (instantaneous dose rate).

RADIATION

total marrow irradiation

TMI will be delivered to all bony sites as part of the conditioning. Additional "spot" therapy to PET positive lesions, primary disease (if not previously irradiated to maximum tolerated dose), and lungs will be performed on Day +60. Cohorts of 3 patients will be treated at a total dose of 600 cGy, 900 cGy or 1200 cGy on Days -11 through -9.

DRUG

Mesna

Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 1.8 g/m\^2/day divided in every 6 hrs dosing for 5 days.

RADIATION

Whole lung radiation

At Day 60, patients with prior lung metastasis should receive whole lung irradiation (1500cGy in 10 fractions).

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Michael R. Verneris, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-08-31

Primary Completion

2012-07-31

Completion

2016-10-31

Countries

• United States

Study Locations