Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors

What Was Tested

This registered phase 1 trial tested Octreotide.

RATIONALE: Radiolabeled octreotide can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells.

It had 1 arm (groups): 90Y-DOTA-tyr3-OCTREOTIDE (experimental).

The registry classes the interventions as radiation.

More on the Plan

Patients receive yttrium Y 90-DOTA-tyr3-octreotide IV over 5-10 minutes on day 1.

Treatment repeats every 6 weeks for up to 3 courses in the absence of unacceptable toxicity.

Patients are followed weekly after each treatment course, 6 weeks after the last course, and then every 6 months thereafter for life.

PROJECTED ACCRUAL: Approximately 25-35 patients will be accrued for this study.

Who Took Part

27 actual participants took part.

It was open to people of any sex aged from 2 years up to 25 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically or cytologically confirmed malignant neoplasm. Not amenable to standard therapy or has failed existing first- and second-line therapies. Tumor positive for somatostatin receptors by OctreoScan within the past 4 weeks. At least 1 measurable lesion. At least 1 measurable somatostatin receptor-positive lesion that has not been irradiated within the past 4 weeks AND has not had full craniospinal radiation within the past 3 months.

The full record lists 50 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2002-01 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Evaluate the short term and long term safety (mild/moderate/severe/life-threatening adverse events, premature discontinuations and serious adverse events) (time frame: short term (6 weeks/cycle); long term (4-6 mos./cycle)).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Octreotide in 27 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.