Trial Information

Summary: (ANHL06P1) A Phase I/II Pilot Study of Ifosfamide, Carboplatin, Etoposide, and Monoclonal Antibody SGN-30 in Pediatric Patients with CD30-Positive Recurrent Anaplastic Large Cell Lymphoma

What is the purpose of this study?
The goals of this research study are:

• To find the safe dose of SGN-30, both alone and with chemotherapy, that can be given without causing severe side effects
• To learn what kind of side effects can be caused by SGN-30, both alone and with chemotherapy
• To learn more about the pharmacology (how your body handles the drug) of SGN-30
• To learn more about the biology (how something works in the body) of SGN-30
• To determine whether SGN-30 is a beneficial treatment against ALCL

Who will be included in the study?
Patients with anaplastic large cell lymphoma who are = 1.00 year and = 21.99 years old are eligible to participate in this clinical trial.

What is involved?
A total of nine (9) drugs will be given to patients on this study, including the experimental drug SGN-30. These drugs are:

1. Ifosfamide (part of ICE chemotherapy)
2. Carboplatin (part of ICE chemotherapy)
3. Etoposide (part of ICE chemotherapy)
4. MESNA (supportive care drug)
5. G-CSF (Granulocyte-Colony Stimulating Factor), supportive care drug
6. Methotrexate (part of triple intrathecal therapy)
7. Cytarabine (part of triple intrathecal therapy)
8. Hydrocortisone (part of triple intrathecal therapy)
9. SGN-30 (experimental drug)

The combination of the first 3 drugs is a common treatment plan used for your type of cancer, called ICE chemotherapy. The drugs that are given in ICE (Ifosfamide/Carboplatin/Etoposide) are well known cancer-fighting drugs. The supportive care drugs (MESNA and G-CSF) help fight the side effects associated with ICE chemotherapy. All drugs, except SGN-30, have been approved for the treatment of cancer for patients by the Food and Drug Administration. Ifosfamide, carboplatin, etoposide, and MESNA will be given through a vein (intravenous infusion). Granulocyte-Colony Stimulating Factor (G-CSF) will be given as a shot into the tissue just under the skin (subcutaneous shot), while methotrexate, cytarabine, and hydrocortisone will be given as intrathecal drugs (through a special needle into the fluid around the spinal cord).

The drugs will be given to patients over 8 weeks of therapy. If patients do not go on to receive a bone marrow transplant (BMT), the same drugs will be given to the patient over about 20 weeks of therapy to complete 6 cycles of ICE.

The patient will also be given several tests and procedures during the study:

• Medical history
• Physical exams
• Vital signs
• Blood tests
• Urine tests
• Bone marrow tests
• Lumbar punctures (Spinal tap)
• X-rays
• CT scans
• Other tests that are needed to check the tumor

These tests are all necessary to make sure that the patient is not having unsafe side effects and to see whether or not the cancer is responding to SGN-30.

What are the benefits?
There may be no direct benefit for the patient if they agree to take part in this research study. The potential benefit of treatment with SGN-30 is that it may cause the patient’s cancer to stop growing or shrink for a period of time. It may lessen the symptoms, such as pain, that are caused by the cancer. Because there is not much information about the effects of SGN-30 on cancers in humans, we do not know if you will benefit from SGN-30. In addition to SGN-30, the patient will also be given ICE chemotherapy, a commonly used regimen that is known to have some effect in lymphoma patients that have relapsed. Even if the patient does not benefit from the SGN-30, they may benefit from ICE chemotherapy. Information learned from this study may help future patients with cancer.

Will I get all the facts about the study?
Patients interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with question or concerns, and more. A member of the study staff will review the consent form with the patient and will be sure that all questions are answered. Study procedures will not begin until a parent/guardian has signed this form, and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects can be provided to those patients interested in knowing more about the study.

Who should I contact for more information?

If you would like to learn more about participating in this study, please send an e-mail message using the form below.