An Eastern Cooperative Oncology Group phase I trial of all-trans-retinoic acid and interferon-alpha : E2Y92

The Eastern Cooperative Oncology Group conducted a Phase I trial to determine the maximally tolerated doses of combination therapy with alpha interferon (IFN-α) and all-trans-retinoic acid (tRA). Fifty patients with incurable malignancies received IFN-α administered subcutaneously three times weekly, and tRA administered by mouth at bedtime. Doses were escalated between patient groups, starting at tRA dose level of 45 mg/m2 and 3 million units of IFN-α.