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WHY CHILDREN
WITH CANCER
NEED PROTECTION


Information about commonly used treatments:

CHEMOTHERAPY

RADIATION

INVESTIGATING TREATMENTS
WITH MEDLINE


WHAT IS CHEMOTHERAPY?

Chemotherapy means the treatment of a disease with the use of chemical agents. In the context of cancer, chemotherapy involves the administration of drugs that are designed to destroy cancer cells by stopping them from growing or multiplying. Healthy cells can also be harmed, especially those that divide quickly. Harm to healthy cells is what causes side effects.

- Source: National Cancer Institute, Chemotherapy and You: A Guide to Self-Help During Cancer Treatment - Understanding Chemotherapy: What Is Chemotherapy? From: NIH Publication #99-1136, Updated: 06/01/1999


CHEMOTHERAPY IS TOXIC AND MAY BE CARCINOGENIC

Nearly every chemotherapy drug used in the treatment of children’s cancers is toxic. In addition, some are also known carcinogens. Incredibly, very few of these drugs have been FDA approved for children. Nonetheless, they are routinely used to treat pediatric cancer. Below are some examples. The sources of this information include: the FDA, Physicians Desk Reference (2002), U.S. Department of Health and Human Services National Toxicology Program Report on Carcinogens, and the International Agency for Research on Cancer (IARC)


Cisplatin

Toxic? Yes. “Cumulative renal toxicity associated with [Cisplatin] is severe…Ototoxicity which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant.”

Carcinogenic? Yes. Cisplatin was listed as “Reasonably Anticipated to be a Human Carcinogen” in the Eighth Report on Carcinogens published by the U.S. Department of Health and Human Services.

FDA Approved for Children? No. Not FDA approved for children. According to the manufacturer, “Safety and effectiveness in pediatric patients have not been established.”

FDA approved only for metastatic testicular cancer, metastatic ovarian cancer and transitional cell bladder cancer.

Carboplatin

Toxic? Yes. “Loss of vision…has been reported…”

Carcinogenic? Unknown. “The carcinogenic potential of carboplatin has not been studied… Carboplatin has been shown to be mutagenic both invitro and invivo.”

FDA Approved for Children? No. Not FDA approved for children. According to the manufacturer, “Safety and effectiveness in pediatric patients have not been established.”

FDA approved only for ovarian cancer.


Cytoxan (Cyclophosphamide)

Toxic? Yes. “[Cyclophosphamide] may cause sterility in both sexes…Serious, sometimes fatal, infections may develop in severely immunosuppressed patients.”

Carcinogenic? Yes. Cyclophosphamide was listed as a “Known Human Carcinogen” by the First Annual Report on Carcinogens published by the U.S. Department of Health and Human Services in 1980.

FDA Approved for Children? FDA approved for malignant lymphomas, leukemias, retinoblastoma and adenocarcimoma.


Etoposide
(VP-16)

Toxic? Yes. “Myelosuppression resulting in death has been reported.”

Carcinogenic? Yes. “[Etoposide] should be considered a potential carcinogen in humans.”

FDA Approved for Children? No. Not FDA approved for children. According to the manufacturer, “Safety and effectiveness in pediatric patients have not been established.”

FDA approved only for small cell lung cancer and testicular tumors.


Thiotepa

Toxic? Yes. “Dosages within and minimally above the recommended therapeutic doses have been associated with potentially life-threatening hematopoietic toxicity.”

Carcinogenic? Yes. “Thiotepa is known to be a human carcinogen based on studies in humans which indicate a causal relationship between exposure to thiotepa and human cancer (reviewed in International Agency for Research on Cancer
V.50, 1990).

FDA Approved for Children? No. Not FDA approved for children. According to the manufacturer, “Safety and effectiveness in pediatric patients have not been established.”

FDA approved only for treating breast cancer.


Topotecan

Toxic? Yes. In pre-marketing tests, 26 out of 112 adults had fever/grade 4 neutropenia and 2 out of 112 died from sepsis (i.e. infection).

“Labels Required: Poison… Death from septicemia and hemorrhage has occurred as a direct result of hematopoietic depression …Exposure to this compound may also result in the development of acute nonlymphocytic leukemia.”

Carcinogenic? Unknown. “Carcinogenicity testing of topotecan has not been performed. Topotecan, however, is known to be genotoxic to mammalian cells and is a probable carcinogen.”

FDA Approved for Children? No. Not FDA approved for children. According to the manufacturer, “Safety and effectiveness in pediatric patients have not been established.”

FDA approved only for treating metastatic ovarian cancer and small cell lung cancer.


Vincristine

Toxic? Yes. “Several instances of convulsions followed by coma have been reported in pediatric patients. Transient cortical blindness and optic atrophy with blindness have been reported.”

“Labels Required: Poison…This compound is highly toxic and may be fatal if inhaled, swallowed or absorbed through the skin.”

Carcinogenic? Unknown. “Neither invivo nor invitro laboratory tests have conclusively demonstrated the mutagenicity of this product.”

FDA Approved for Children? FDA approved only for treating Wilm’s tumor and leukemias.


CHEMOTHERAPY MAY BE INEFFECTIVE

Besides being toxic, carcinogenic and not approved for children, some chemotherapy drugs and drug combinations have proven to be ineffective in the treatment of some pediatric cancers. Despite this knowledge, some oncologists continue to use the same drugs in the treatment of the same cancers. Below is one example:

Topotecan

Effective? Below are two studies that demonstrate that the chemotherapy drug called “Topotecan” is “inactive” or has “insufficient activity” in pediatric central nervous system tumors:

“Topotecan administered as a 24-hour infusion every 21 days is inactive in high grade gliomas, medulloblastomas, and brain stem tumors.” (emphasis added)

- Blaney SM, et al., Phase II evaluation of topotecan for pediatric central nervous system tumors. Cancer 1996 Aug 1;78(3):527-31

“It was concluded that topotecan as given according to this schedule showed insufficient activity to promote it to frontline protocol usage.” (emphasis added)

- Kadota RP, et al., Topotecan for the treatment of recurrent or progressive central nervous system tumors - a pediatric oncology group phase II study. J Neurooncol 1999 May;43(1):43-7

Despite the fact that “Topotecan” has been called “inactive” or has “insufficient activity” in pediatric central nervous system tumors, it is still being used in children with the same cancers.

St. Jude Children’s Research Hospital has labeled Topotecan as “new,” “promising,” and “active” despite the fact that this hospital has participated in the studies that called it “inactive” and showing “insufficient activity.”

- St. Jude Children’s Research Hospital, Innovative Treatments: Treatment of newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumors, and atypical teratoid rhabdoid tumors.

And a national study involving many pediatric hospitals is currently recruiting children with brain tumors in order to administer topotecan directly into their spines.

- Phase II Study of Intrathecal Topotecan in Pediatric Patients With Refractory Meningeal Malignancy; CCG-P9962, NCI-01-C-0123, POG-9962

 

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